International Journal of Pharmaceutical Investigation <p style="text-align: justify;"><strong>International Journal of Pharmaceutical Investigation</strong> publishing peer-reviewed scholarly reviews, themed issues and research articles within the entire scope of Pharmaceutical Sciences. The journal particularly aims to foster the dissemination of scientific information by publishing manuscripts related to current pharmaceutical drug delivery and related fields and submission of uninvited expert reviews and research articles in all areas of pharmaceutical drug delivery are welcomed. The journal publishes the following categories of manuscripts: research papers presenting original research, reviews, short communications, letter to the editor, commentaries, etc. including critical review articles providing a comprehensive analysis of research development within a defined area and editorial commentaries on key topical issues in pharmaceutical drug delivery.</p> <p style="text-align: justify;"><strong>Subjects covered in the journal</strong></p> <p style="text-align: justify;">The journal aims to cater for the latest outstanding developments in the field of Pharmaceutical Sciences and Technology covering the following topics (non-limiting):</p> <ul style="text-align: justify;"> <li class="show">Pharmaceutics</li> <li class="show">Nanotechnology</li> <li class="show">Current Novel Drug Delivery Systems</li> <li class="show">Quality control of Pharmaceuticals</li> <li class="show">Quality Assurance</li> <li class="show">National and International Regulatory Affairs</li> <li class="show">Validation Techniques</li> <li class="show">Industrial Pharmacy</li> <li class="show">Biopharmaceutics and Drug Disposition</li> <li class="show">Pharmacokinetics</li> <li class="show">Drug Development</li> <li class="show">Pharmaceutical Intellectual Property Rights.</li> </ul> <p style="text-align: justify;"><strong>Other Allied Pharmacy Subjects</strong></p> <ul> <li class="show" style="text-align: justify;">Pharmacognosy &amp; Ethnopharmacology</li> <li class="show" style="text-align: justify;">Pharm Chemistry &amp; Medicinal Chemistry&nbsp;</li> <li class="show" style="text-align: justify;">Pharmacology&nbsp;</li> <li class="show" style="text-align: justify;">Pharmacy Practice</li> <li class="show" style="text-align: justify;">Others</li> </ul> EManuscript en-US International Journal of Pharmaceutical Investigation 2230-973X Green Indicators-An Ecofriendly Endpoint <p>Although acid-base titrations can be done using numerous indicators which are either synthetic or semi-synthetic, the investigation was started for natural compounds as the former ones result in polluting the habitat despite their limited availability, complicated method of preparation, and expensiveness. Equivalence point determination is the point of interest in neutralization titrations. With the change in pH, the indicators which are natural, usually end up giving a sharp color change. Plant-derived pigments that are of various shades and tints generally vary in their dyeing nature by altering pH. An indicator is a substance that exhibits the property of interchangeable color of the reaction mixture when reaching the vicinity of point with the change in pH. Acid-base titration indicators are normally weak acids or bases. Hibiscus rosa-sinensis, Ipomoea biloba, Dahlia pinnata, etc. are among the typical neutralization indicators that are extracted from plants. These natural Indicators are easily available and economical. In this review, we are discussing an overview of plant extracts, and natural pH indicators, and their significance in correspondence to analytical chemistry is illustrated.</p> Sri Nataraj Kalakonda Srinivasa Rao Atla Roja Naveena Puvvada Prapul Kumar Nalli Ijaz Sheik Rajendra Prasad VVS ##submission.copyrightStatement## 2023-03-02 2023-03-02 13 2 206 214 10.5530/ijpi.13.2.028 A Detailed Insight of Monkey Pox Virus Infection in Adolescent <p style="text-align: justify;"><strong>Background: </strong>Smallpox-like symptoms are seen in the viral zoonotic illness known as monkeypox. In the current outbreaks being reported, the World Health Organization (WHO) claims that this is the first instance of chains of transmission being documented in Europe without known epidemiological connections to West or Central Africa. On August 7, 2022, the WHO reported a total of 27,815 confirmed cases in over 89 countries, with the majority of those affected experiencing monkeypox for the first time. The objective of this article is to provide a succinct overview of the monkey pox, its transamission mechanisms, and available preventative methods in adolescents. <strong>Materials and Methods:</strong> Several databases, including WHO guidelines, PubMed, Bentham Science, and Elsevier, were used to compile the data for the article following a thorough analysis of the various research findings connected to monkey pox infection, pathogenesis, and available treatments. <strong>Results:</strong> Monkeypox is a zoonotic orthopoxvirus that causes disease in humans similar to smallpox. Complications are more likely in children and the immunocompromised. Treatment is largely symptomatic. The first-line treatment for monkeypox, including in kids and teenagers, is tecovirimat. <strong>Conclusion:</strong> We came to the conclusion from this review that adolescents and adults both transmit the monkey pox virus. The most common sign of monkeypox in kids and teens is a rash that starts out as maculopapular lesions and turns into vesicles, pustules, and then scabs, just like diseases in adults. Children and adolescents who have been exposed to individuals with suspected or confirmed monkeypox may benefit from Post-Exposure Prophylaxis (PEP) with vaccination, immune globulin, or antiviral medicine.</p> Ankita Wal Garima Vishnoi Divyanshi Gupta Parul Srivastava Pranay Wal Awani K Rai ##submission.copyrightStatement## 2023-03-02 2023-03-02 13 2 215 223 10.5530/ijpi.13.2.029 An Overview of Corrective Action and Preventive Action <p>Corrective and Preventive Actions (CAPA) are crucial for enhancing and raising the quality of the finished good or service. It is essential to every industry's ongoing development. In any pharmaceutical or medical device sector, the main goal of Corrective Action and Preventative Action (CAPA) is to identify any weaknesses, deviations, or failures and conduct an inquiry, and take the necessary corrective action to ensure that these issues don't recur. An approach known as CAPA also entails taking preventive actions right away to stop any incidence from happening in the first place. In a pharmaceutical company, it is both a legal necessity and a component of the broader Quality Management System (QMS). The corrective and preventive action subsystem is governed by 21 CFR 820.100, which lays out the rules (CAPA).</p> Shantanu S Thakre MP Venkatesh Rohit S Gahilod ##submission.copyrightStatement## 2023-01-04 2023-01-04 13 2 224 230 10.5530/ijpi.13.2.030 Development of a Floating Drug Delivery System for Prolonged Release of Metronidazole in the Stomach for Gastrointestinal Infection <p style="text-align: justify;"><strong>Introduction: </strong>Gastroretentive Drug Delivery System like floating tablets out performs traditional dosing forms. When compared to conventional tablets, floating tablets have higher bioavailability, higher drug concentration in the systemic circulation, and lower frequency of dose. Metronidazole floating tablets were formulated using a variety of polymer combinations by the direct compression process. Polyvinyl pyrrolidone (PVP K30), Guar gum, and Xanthum gum are the polymers employed in the composition. <strong>Materials and Methods: </strong>The drug-excipient compatibility was determined by FTIR Spectroscopy and a total of nine formulations of floating tablets have been prepared. Among these, an appropriate formulation was chosen. The angle of repose, Bulk, and tapped density of metronidazole tablet mixes were previously evaluated. Carr's index, Hauser's ratio, physical appearance, hardness, weight fluctuation, friability, floating qualities, and <em>in-vitro</em> dissolving testing were used to characterize the tablets. <strong>Results: </strong>The flow properties were found optimum in all the pre-compression parameters and hence suitable for the direct compression method. The evaluation of tablets showed a good floating effect of about 4-7 hr in almost all the formulations. The floating tablets showed drug release of more than 90% after 6 hr and hence gastric retention was achieved. The study findings revealed that formulation 3 was the best, with a floating lag time of less than a minute and more than 7 hr of retention in the gastric pH with optimum floating behavior and drug release in the stomach. <strong>Conclusion: </strong>Hence, the prepared floating system involving a combination of polymers was found to be a reliable tool for gastric retention.</p> Aanantha Kumaran Sruthi Laakshmi M Gouranga Dutta Abimanyu Sugumaran Damodharan Narayanasamy ##submission.copyrightStatement## 2023-03-02 2023-03-02 13 2 231 237 10.5530/ijpi.13.2.031 Evaluation of Sono-photocatalytic Removal of Ciprofloxacin Antibiotic Using Magnesium Oxide Nanoparticles from Aqueous Solutions <p style="text-align: justify;"><strong>Objectives: </strong>The entry of antibiotics into surface and groundwater will cause problems in the environment. This study aimed to investigate the removal efficiency of ciprofloxacin (CFX) from aqueous solutions using the sonophotocatalytic process of Magnesium Oxide Nanoparticles (MgO). <strong>Materials and Methods: </strong>This study is an experimental-laboratory study performed in a reactor with a discontinuous system. In this study, the effect of parameters such as solution pH, MgO dose, reaction time in two processes, photocatalyst and sonocatalyst, initial concentration of antibiotic and the power of UV lamps in the photocatalytic reactor at ultrasonic frequencies of 35 and 130 kHz on the reduction of CFX in aqueous solution was investigated. <strong>Results: </strong>The results showed that the process of photosonocatalysis with MgO can effectively lead to the removal of the antibiotic CFX. In the process of using a photosonocatalyst with a pH of 7 and ultrasonic waves with a frequency of 35 kHz and an optimal time of 30 min, 0.3 g/L of MgO, CFX concentration of 150 mg/l, UV lamp with a power of 30 watts and the optimal irradiation time of 60 min was obtained as the optimal variables in the removal of CFX antibiotic. <strong>Conclusion: </strong>The results showed that the photosonocatalytic process with the help of MgO is an effective and efficient method to remove the CFX antibiotic from aqueous solutions.</p> Ferdos Kord Mostafapour Mohammadreza Radmehr Shaziya Haseeb Siddiqui Davoud Balarak ##submission.copyrightStatement## 2023-03-02 2023-03-02 13 2 238 242 10.5530/ijpi.13.2.032 Co-crystals: A Novel Approach to Improve the Solubility of Apixaban <p style="text-align: justify;"><strong>Objectives: </strong>The current study work was aimed to improve the solubility of Apixaban by forming co-crystals. <strong>Materials and Methods:</strong> Two solvents mainly Dimethyl Sulphoxide (DMSO) and 2,2,2-trifluoroethanol were tried during the formulation of co-crystals. The other chemicals oxalic acid, adipic acid and L-Tartaric acid were used. <strong>Results: </strong>From the different trials it was concluded that oxalic acid and DMSO combination with the drug gave the better results for improvement in the solubility. Hence the batch F3 was analysed further. The melting point of F3 was found lower than pure drug. Drug content was found optimum as 95.06 ±0.65%. FTIR-spectra demonstrated the combined peaks of drug and oxalic acid. DSC thermogram showed the sharp endothermic peak similar to pure drug. SEM and XRD spectra confirmed the formation of co-crystals. <strong>Conclusion: </strong>It was found that formation of co-crystals of apixaban and oxalic acid was satisfactory and it was beneficial to improve the solubility of the apixaban.</p> Amit V Asati Kishor S Salunkhe Rudra Pratap Singh Rajput Sonali R Chintamani Akshay U Khairnar Nilesh S Patil Ravindra N Chintamani ##submission.copyrightStatement## 2023-03-02 2023-03-02 13 2 243 247 10.5530/ijpi.13.2.033 Evaluation of Anthelmintic Activity and GC-MS Characterization of Urochloa distachya (L.) <p style="text-align: justify;"><strong>Background: </strong>The helminthiasis parasitic worm present in the gastrointestinal tract of the animal cause infection and physiological damage. This occurs due to poor sanitation, impecunious personal hygiene, low socioeconomic position, and lack of education. Aim: <em>Urochloa distachya</em> (Poaceae) commonly called as signal grass and used as fodder for the animal. The present investigation was undertaken to investigate the phytochemicals and to study the anthelmintic activity. <strong>Materials and Methods:</strong> The plant material was extracted by using petroleum ether and methanol in Soxhlet apparatus and the obtained extract was subjected to GC-MS analysis for the identification of the bioactive components responsible for anthelmintic activity. The anthelmintic activity was performed against earthworms (<em>Eisenia fetida</em>) at concentrations 12.5, 25, and 50 mg/mL using piperazine citrate as standard. <strong>Results:</strong> The GC-MS analysis of the petroleum ether extract showed five major and ten minor compounds. The major compounds were identified as Stigmasterol (14.76%); α-Amyrin (12.47%); γ-Sitosterol (10.31%); 17-(1,5-Dimethyl-3-phen ylthiohex-4-enyl) -4,4,10,13,14-pentamethyl 2,3,4,5,6,7,10,11,12-(9.12%) and β-Amyrin (8.83%). The minor compounds were D:C-Friedo-B': A'-neogammacer-9(11)-ene, 3-methoxy-, (3β)-(8.28%); Tritetracontane (7.23%); Campesterol (4.68%); Phytol (4.05%); Cholesterol (3.39%); Hexadecanoic acid, methyl ester (2.20%); 2-Pyrrolidinone, 1-methyl-(1.46%); Oleic acid, 3-(octadecyloxy) propyl ester (1.27%); Squalene (0.84%) and 9,19-Cyclolanostane-3,7-diol (0.68%). The time taken for paralysis and death of Eisenia fetida parasite was noticed by methanolic and petroleum ether extract at a concentration of 50 mg/kg as compared to the standard drug. <strong>Conclusion: </strong>The anthelmintic activity of the plant was most achieved by methanolic extract which could be attributed to the presence of the Octadecanoic acid. Also, the anthelmintic active of the petroleum ether extract could be attributed to the antimicrobial, antibacterial, antifungal, and antiprotozoal activities of the Hexadecanoic acid, methyl ester; Phytol; Squalene; Cholesterol, and γ-Sitosterol.</p> Smrutiranjan Dash Janki Bohidar Chandan Das Arnabaditya Mohanty Ashutosh Meher Raghunandan Hota ##submission.copyrightStatement## 2023-03-02 2023-03-02 13 2 248 254 10.5530/ijpi.13.2.034 In-vitro Antioxidant and Antitumor Activity of Dihydropyrimidine-2(1-H)-thione Derivatives with Carbazole Moiety <p style="text-align: justify;"><strong>Aim:</strong> Prepared a series of molecules called Dihydropyrimidine-2(1-H)-thione of carbazole to evaluate antioxidant and antitumor activity. <strong>Materials and Methods: </strong>Compounds from DTP-1 to DTP-11 were prepared and subjected for Spectral analysis like infrared, <sup>1</sup>H NMR, and Mass spectroscopy. Further evaluated antioxidant property of molecules using DPPH free radical scavenging method and analyzed the antitumor activity by MTT assay. <strong>Results:</strong> The molecule DTP-4 (4-(9H-carbazol-9-yl)-6-(3-hydroxyphenyl)-5,6-dihydropyrimidine-2(1H)-thione) exhibit the spectral values i.e, Mass, m/z: 371.08, 166.45; IR (KBr) ν<sub>max</sub>, cm<sup>−1</sup>: 3420 (NH Str), 3567(O-H); <sup>1</sup>H NMR (MHz, δ): (15H, Ar-H) 8.003-7.019, (1H, N-H) 11.129, (1H, O-H) 10.03 and DTP-6: 4-(9H-carbazol-9-yl)-6-(4-Dimethylamino-phenyl)-5,6-dihydropyrimidine-2(<sup>1</sup>H)-thione Mass value of m/z: 398.03, 166.09; IR (KBr)<sub>vmax</sub>, cm<sup>−1</sup>: 3419 (NH Str), (Ar C=S); <sup>1</sup>H NMR (MHz, δ): (15H, Ar-H) 8.128-7.121, (1H, N-H) 11.290, (6H, -N-(CH<sub>3</sub>)<sub>2</sub>)3.491-2.791. <strong>Conclusion: </strong>Among all of those prepared molecules, DTP-4, which includes the functional group (3-OH) ortho-hydroxy, has an IC<sub>50 </sub>value of 2.32 μm against the Jurkat T cell line while compound DTP-06, which contains the functional group 4-dimethylamino, exhibits an IC<sub>50</sub> value of 05.39 μm against the HeLa cell line.</p> Purushotham KN Bevinahalli Ramesh Thoppalada Yunus Pasha ##submission.copyrightStatement## 2023-03-02 2023-03-02 13 2 255 260 10.5530/ijpi.13.2.035 Development and Validation of Stability Indicating RP-HPLC Method for Quantitative Estimation of Enzalutamide in Enzalutamide Capsules Dosage Form <p style="text-align: justify;"><strong>Objectives:</strong> A precise, accurate and selective stability-indicating reverse phase high performance liquid chromatographic assay method has been developed for the quantitative estimation of Enzalutamide in Enzalutamide capsules dosage form.<strong> Materials and Methods</strong>: The separation was achieved by using a stationary phase Waters X-Bridge Shield RP18 (150 x 4.6 mm, 3.5μ) and the mobile phase consisted of perchloric acid buffer and acetonitrile in the proportion of (20:80 volume/volume). The run velocity was 1.2 mL/min. Enzalutamide was identified using UV detector at the wavelength of 210 nm. Column oven temperature 25°C and sample cooler temperature 25°C and infused quantity 20 μL, run time was 15 min.<strong> Results:</strong> As there is no meddling flanked by blank and placebo at the retention time of Enzalutamide. Degradation study results were shown significant degradation was observed in acid and oxidation (peroxide) stress condition. Hence it can be concluded that Enzalutamide is sensitive to acid and oxidation. To obtain system precision, a study was conducted with six replicate injections. %RSD was estimated from the peak areas of Enzalutamide establish to be 0.55% correspondingly. The relative standard deviation for method exactitude was establish to be 0.55%. The suggested HPLC technique was linear over the range of 100.6-301.8 μg/mL, the correlation coefficient was establish to be 0.9999. The accuracy studies were shown as % recovery for Enzalutamide 50% to150% level. The limit of % recovered revealed is in the assortment of 98 and 102% and the consequences obtained were establish to be within the limits. Hence the technique was establish to be accurate. The solution steadiness of the standard and samples are stable upto 48 hr on a bench top and refrigerator (2-8°C). The method is robust for changes like flow rate and column oven temperature. Performed the filter validation for sample solution 0.45 μm PVDF and 0.45 μm Nylon filterers are suitable for filtration. The method has validated as per ICH guidelines and all the validation parameters are satisfy the ICH Q2 specification acceptance limits. <strong>Conclusion: </strong>The developed method was validated for an assortment of parameters as per ICH guidelines like accuracy, precision, linearity, specificity, system suitability, solution stability and robustness. The consequences obtained were within the acceptance criteria. So, it can be concluded that the urbanized technique is simple, precise, cost-effective, eco-friendly, and safe and can be successfully employed for the routine analysis of Enzalutamide in bulk and pharmaceutical dosage forms.</p> DSVN Sitamahalakshmi P Bharath D Ramachandran DSVNM Ramamurty ##submission.copyrightStatement## 2023-03-02 2023-03-02 13 2 261 269 10.5530/ijpi.13.2.036 Stability Indicating HPLC Method for Simultaneous Assessment of Clopidogrel Bisulfate and Aspirin: Development and Validation <p style="text-align: justify;"><strong>Objectives: </strong>The efforts were made to develop a HPLC analytical method for the simultaneous quantitative estimation of aspirin and clopidogrel and aim to identify and estimate the degradation of the drugs under the various stress conditions recommended by ICH guideline. <strong>Materials and Methods:</strong> The separation of two drugs were done by using LC-20AD liquid chromatograph having SPD-20A UV-vis detector on C<sub>18</sub> (4.6 x 150 mm) column which was connected with loop 20μl and with HPLC-Dell system. Mobile phase consisted of acetonitrile: buffer in the ratio of 350:650 v/v. Flow rate was 1.3 ml/min and detection were done at 220 nm. Proportions of solvents and adjustment of mobile phase was carried out by screening. <strong>Results: </strong>The chromatographic separation of aspirin was noted at 4.299 minutes with average USP tangent of 8332.046 and clopidogrel was at 12.706 min with average of 11886.0397 tangent. A linear correlation was observed between concentration of aspirin and clopidogrel with their dilutions i.e r<sup>2</sup> = 0.9986 and 0.9996 respectively. The outcome of study, with limit of detection 0.058 and 0.078 μg/ml and limit of quantification 0.117 and 0.156 μg/ml, for aspirin and clopidogrel revealed the repeatability, reproducibility and robustness of the method. Stability indicating parameters were tested by ICH guideline. <strong>Conclusion:</strong> It is concluded that the method is linear, reproducible, robust, rugged and stability-indicating for simultaneous calculation. It can be used as a routine quality control method for combined pharmaceutical dosage form and for its kinetic studies.</p> Shahnaz Usman Muhammad Akram Fasiha Shah KVRNS Ramesh Quamrul Islam ##submission.copyrightStatement## 2023-03-02 2023-03-02 13 2 270 278 10.5530/ijpi.13.2.037 Stability Indicating RP-HPLC Method for Quantitative Estimation of Levetiracetam and its Impurities in Pharmaceutical Dosage Form <p style="text-align: justify;"><strong>Objectives:</strong> A simple, precise, accurate, robust and selective stability-indicating reverse phase high performance liquid chromatographic method for the separation and quantification of Levetiracetam and its impurities in Levetiracetam liquid dosage formulations. <strong>Materials and Methods: </strong>The analysis of improved RP-HPLC method for the separation and quantification of Levetiracetam and its impurities are described. Samples are analysed by means of reverse phase (RP-HPLC) using an Inertsil ODS-3V, 150 x 4.6 mm, 3μm and the mobile phase consists of two channels A and B. Channel-A: pH 5.50 phosphate buffer : acetonitrile (950:50 v/v) and channel-B: acetonitrile: water (90:10 v/v). The flow rate is 1.0 ml/min. The column temperature was maintained at 40°C and sample temperature was maintained at 25°C, injection volume 10μL and wavelength fixed at 205 nm. <strong>Results</strong>: For selectivity, the chromatograms were recorded for standard and sample solutions of Levetiracetam and its related substances. Selectivity studies reveal that the peak is well separated from each other. Therefore the method is selective for the determination of related substances in Levetiracetam. There is no interference of diluent and placebo at Levetiracetam and impurities peaks. The elution order and the retention times of impurities and Levetiracetam obtained from individual standard preparations and mixed standard preparations are comparable. The limit of detection (LOD) and limit of quantitation (LOQ) for Levetiracetam standard 0.0023% and 0.0070%, impurity-A 0.0049% and 0.0147%, impurity-C 0.0024% and 0.0074% and Levetiracetam RC-A 0.0091% and 0.0277% respectively. The linearity results for Levetiracetam and all the impurities in the specified concentration range are found satisfactory, with a correlation coefficient greater than 0.99.Calibration curve was plotted and correlation co-efficient for Levetiracetam and its impurities found to be 1.000, 0.9999, 1.000 and 0.9994 respectively. The accuracy studies were shown as %recovery for Levetiracetam and its impurities at specification level. The limit of % recovered shown is in the range of 80 and 120% and the results obtained were found to be within the limits. Hence the method was found to be accurate. For precision studies six replicate injections were performed. %RSD was determined from the peak areas of Levetiracetam and its impurities. The acceptance limit should be not more than 10, and the results were found to be within the acceptance limits. <strong>Conclusion: </strong>The developed LC method was validated with respect to specificity, precision, linearity, ruggedness and robustness. Validation study compared as per ICH guideline.</p> P Venkateswara Rao V Anuradha D Ramachandran CV Nageswara Rao ##submission.copyrightStatement## 2023-03-02 2023-03-02 13 2 279 289 10.5530/ijpi.13.2.038 A Green Eco-friendly Analytical Method Development, Validation, and Stress Degradation Studies of Favipiravir in Bulk and Different Tablet Dosages Form by UV-spectrophotometric and RP-HPLC Methods with their Comparison by Using ANOVA and in-vitro Dissolut <p style="text-align: justify;">Favipiravir is an antiviral drug with significant and widespread antiviral action. Favipiravir was crucial in the contest against the COVID-19 pandemic because of how well it treated the SARS-CoV-2 virus. It is well known that contemporary pharmaceutical analysis establishes green, stability-indicating analytical procedures. The current study aimed to develop and assess UV-spectrophotometric (zero order, first order, area under the curve) and RP-HPLC methods for estimating favipiravir in its pharmaceutical dose form, comparing them using ANOVA and an <em>in-vitro</em> dissolution analysis. A green solvents composition of methanol, ethanol, and water (25:35:40 v/v/v) is used for analysis as a mobile phase and diluent. Method A is a simple zero-order spectrophotometric method for determining favipiravir at 236 nm, and the correlation coefficient in the linearity study was found to be 0.9962, LOD, and LOQ are 0.18 and 0.55 μg/mL. Method B is a first-order spectrophotometric method for determining favipiravir at 227 nm, and the correlation coefficient in the linearity study was found to be 0.9964, LOD, and LOQ are 0.64 and 1.96 μg/mL. Method C is an area under the curve spectrophotometric method for determining favipiravir at 230 to 243 nm, and the correlation coefficient in the linearity study was found to be 0.9986, LOD, and LOQ are 0.32 and 0.96 μg/mL. Method D is the RP-HPLC method for the determination of favipiravir at the retention time of 7.216 min, a flow rate of 0.80 mL/min, column temperature of 25°C, at 236 nm, Isocratic mode, and the correlation coefficient in the linearity study was found to be 0.9996, LOD, and LOQ are 0.52 and 1.56 μg/mL. All developed methods demonstrated good repeatability and recovery with %RSD &lt; 2. The proposed established methods were assessed using one-way ANOVA. It was revealed that the F<sub>calculated</sub> value was lower than the F<sub>tabulated</sub> value, with no discernible variation in the assay results. Studies on stress degradation show that oxidation and acid degradation mostly impact favipiravir solutions. The Analytical Eco-scale verified that these methods are the greenest and most environmentally friendly, enabling the suggested approach to use an effective green analytical methodology to measure favipiravir extensively. Phosphate buffer (pH 6.4) was the best dissolution medium after analysis of the favipiravir dissolution study in several dissolution media.</p> Subhadip Chakraborty Sumanta Mondal ##submission.copyrightStatement## 2023-03-02 2023-03-02 13 2 290 305 10.5530/ijpi.13.2.039 A Stability Indicating RP-HPLC Method for Simultaneous Estimation of Acebrophylline, Montelukast, and Fexofenadine in Bulk and Pharmaceutical Dosage Forms <p style="text-align: justify;"><strong>Introduction:</strong> The goal of the current work is to create an RP-HPLC method for the quantitative analysis of Acebrophylline, Montelukast, and Fexofenadine in Pharmaceutical dosage form. <strong>Materials and Methods:</strong> Chromatographic separation of Acebrophylline, Montelukast and Fexofenadine was executed on Waters Alliance-e2695, by using Hyper clone 5μ BDS C<sub>18</sub> 130A (250 x 4.6mm) column and the mobile phase consisting of Methanol: Ammonium formate adjusted to pH-6 and ortho phosphoric acid (70:30). The flow rate: 1.0 mL/min, Column temperature: 25°C and detection wavelength 268nm utilizing a photodiode array detector. <strong>Results and Discussion:</strong> According to ICH criteria, the new approach was validated, and forced degradation tests are also carried out. The procedure is effective for the precise identification and quantification of the three medicines in relation to all of the revealed validation factors. The technique also shows to be suitable for identifying chemical degradation. <strong>Conclusion:</strong> Therefore, the approach created can be utilized for quality control and routine laboratory analysis of these particular medications.</p> Sreedevi Adikay Mounika Bhavanasi Sai Sruthi Kaveripakam ##submission.copyrightStatement## 2023-03-02 2023-03-02 13 2 306 312 10.5530/ijpi.13.2.040 Synthesis, Characterization, RP-HPLC Method Development and Validation for Qualitative Estimation of (4Z) 3 Methyl 1 (4 Nitrobenzoyl) 1H Pyrazole 4,5 Dione 4[(4fluorophenyl) Hydrazone] <p style="text-align: justify;"><strong>Aim:</strong> A new simple, accurate, precise, Reverse Phase High-performance Liquid Chromatography method was developed and validated for the estimation of newly synthesized (4Z) 3 methyl 1 (4 nitrobenzoyl) 1H pyrazole 4,5 dione 4[(4fluorophenyl)hydrazone] derivative of pyrazolone. <strong>Materials and Methods:</strong> The chromatogram was run through Luna 5μ C<sub>18</sub>(2). 250 × 4.80 mm. 272817-7 HPLC column; mobile phase consisting of acetonitrile and water in the ratio 90:10 was pumped through the column at a flow rate of 0.8mL/min. <strong>Results:</strong> The optimized wavelength was 237 nm. The retention time of (4Z) 3 methyl 1 (4 nitrobenzoyl) 1H pyrazole 4,5 dione 4[(4fluorophenyl)hydrazone] was found to be 7.3 min. The percentage relative standard deviation was obtained as 0.3%. <strong>Conclusion:</strong> This method was accurate, precise, and sensitive; therefore, could be used for the quality control and bioanalytical evaluation of (4Z) 3 methyl 1 (4 nitrobenzoyl) 1H pyrazole 4,5 dione 4[(4fluorophenyl)hydrazone] in drug testing laboratory.</p> Harsha Ashtekar Natasha Aggarwal Chaitra Raviraj Gupta Dheeraj Rajesh Nimmy Varghese ##submission.copyrightStatement## 2023-03-02 2023-03-02 13 2 313 320 10.5530/ijpi.13.2.041 Fluorescence Emission and Molecular Docking Studies Identified Novobiocin as a Potent Inhibitor of the Japanese Encephalitis Virus (JEV) Envelope Protei <p style="text-align: justify;"><strong>Introduction:</strong> The Japanese Encephalitis Virus (JEV) causes the acute inflammatory disease of the central nervous system known as Japanese encephalitis. JEV is a RNA virus (+strand) that is tiny, enclosed, and from the family Flavivirus. The envelope protein (E), which facilitates JEV entrance into the host cell, has been chosen as a possible molecular aim for therapeutic progress in this work.<strong> Materials and Methods: </strong>The 3D structure of E protein was retrieved from RCSB PDB (id: 3P54). The sdf files of four lead molecules namely etoposide, netropsin, nogalamycin, and novobiocin were downloaded from the PubChem and used for molecular docking against JEV E protein. We then assessed the fluorescence emission intensity of JEV alone and JEV bound to novobiocin at 280–500 nM to confirm the inhibition of JEV by Novobiocin. The secondary structure of JEV was ascertained by measuring its CD spectra. The CD spectra of JEV were examined as a function of temperature to evaluate the protein constancy. <strong>Results</strong>: Our docking and fluorescence emission spectra results showed that JEV E pro has good binding preference for novobiocin among these four test compounds. Moreover, fluorescence emission spectra of JEV E protein with novobiocin also revealed the 5 μM concentration is an effective novobiocin concentration to inhibit the activity of target protein. One top ranked lead molecule namely novobiocin with strong binding affinity (-8.574 Kcal/mol) to JEV E protein was known based on binding energy. Results of the CD Spectra made it quite evident that there is no random coil. Peaks in the negative range (troughs) at 210–230 nm in the CD spectra indicate that JEV has a secondary structure rich in helices. The data unambiguously show that there is no appreciable variation in the JEV curves. <strong>Conclusion: </strong>Conclusion of the current work offer a thorough understanding of how the JEV E protein is inhibited and provide information that will help novobiocin be developed as a therapeutic drug against JEV E protein in certain viral diseases.</p> Afaf S Alwabli ##submission.copyrightStatement## 2023-02-02 2023-02-02 13 2 321 328 10.5530/ijpi.13.2.042 A Pilot Study on Medication Adherence, Patient Satisfaction, KAP and Quality of Life of Hypertensive Patients <p style="text-align: justify;"><strong>Aim:</strong> The present study was designed as a pilot study to assess the prevalence and reasons for occurrence of hypertension and identify the various treatment options prescribed and to determine the patients’ awareness and adherence to the treatment. <strong>Materials and Methods:</strong> An institution based cross-sectional study for a period of one month was conducted among the patients of Department of General Medicine, DM WIMS Multispecialty Hospital, Wayanad, Kerala by using standard questionnaires. 51 patients who meet the inclusion criteria were enrolled in the study. Well-structured questionnaires and standard tools such as Patient Satisfaction Scale (SAPS), Hill-Bone medication adherence scale (HB-MAS), WHOQOL-BREF were utilized to collect the data. Collected data was scrutinized by using Statistical Package for Social Sciences (SPSS version 15.0). Student t-test and one-way ANOVA were employed to test for associations at 95% confidence interval. P&lt;0.05 were considered significant. <strong>Results: </strong>The Results indicated rise of prevalence of hypertension in rural regions. Middle ged male group was mostly affected. Majority of the participants were affected with Grade III hypertension for more than five years and also affected with other chronic illness. All the study subjects were treated with multi-therapy regimen with dose frequency of BID. Results showed a lesser level of treatment satisfaction, medication adherence, KAP and quality of life of study population. <strong>Conclusion: </strong>The results strongly supported the need of the patient counselling by clinical pharmacists to improve the analysed parameters. Hopefully, future study with larger sample size with proper patient counselling could provide a significant outcome.</p> Dilipkrishnan K Gopalakrishnan G ##submission.copyrightStatement## 2023-03-02 2023-03-02 13 2 329 334 10.5530/ijpi.13.2.043 Evaluation of Knowledge, Attitude and Practice towards Hypothyroidism among Population in Moradabad District: A Pilot Study <p style="text-align: justify;"><strong>Introduction:</strong> Thyroid problems are thought to be a widespread health problem in India, as they are across the world. However, there is a lack of data on these patients' knowledge, attitude, and practices (KAP). <strong>Objectives: </strong>The goal of this study is to create and validate a questionnaire and to assess the knowledge, attitude, and practices of population towards hypothyroidism. <strong>Materials and Methods:</strong> There were two phases to the questionnaire: development and validation. A literature review and evaluation are all part of the development phase. The validation phase entailed determining the questionnaire's suitability by evaluating factors such as clarity, simplicity, accuracy, and relevance using scores provided by lingual experts and Institutional ethical committee members. <strong>Results: </strong>The current cross-sectional study was conducted on 50 random participants over the age of 20 live in Moradabad District. Cronbach's alpha was used to determine the consistency of replies to individual items and the entire questionnaire. Questionnaire's overall standardized alpha value was 0.821, which is an excellent Cronbach score and suggests good homogeneity. The self-structured questionnaire comprises of KAP based 30 yes, no, or don't know items. The majority of the participants were between the ages of 30-40. 24% were unable to identify the thyroid gland's primary activities. 86% agreed that hypothyroidism is inherited and that they should monitor their thyroid levels on a frequent basis. In terms of adherence, 80% of the individuals were found to be following their treatment plan.</p> Rahul Arora Piyush Mittal Jyoti Trivedi Anurag Verma ##submission.copyrightStatement## 2023-03-02 2023-03-02 13 2 335 343 10.5530/ijpi.13.2.044 Prevalence of Depression and Anxiety among General Population during COVID-19 Second Wave in Saudi Arabia <p style="text-align: justify;"><strong>Introduction: </strong>Coronavirus 2019 (COVID-19) Pandemic had serious impact on people’s mental health in the 21<sup>st</sup> century. Mental disorders have inuenced economically on the society and have a dramatic eect on families too. This study aims to assess the eects of COVID-19 on psychological outcomes of pandemic and its associated risk factors on the general population of Saudi Arabia.<strong> Materials and Methods:</strong> A cross-sectional survey was conducted by distributing the questionnaires electronically in Saudi Arabia from 1<sup>st </sup>March 2021 to 30<sup>th</sup>April, 2022. PHQ-9, GAD-7 and PSQ-30 were used to assess the prevalence of depression and anxiety among population. A total of 1532 participants completed the study. <strong>Results: </strong>The prevalence of depression, anxiety, and stress was 25.1%, 42.5%, and 68.48%, respectively. Signicant predictors were Saudi nationals, young and single participants, less earning and respondents with no children. The mean depression score was signicantly higher in participants that had not been infected with COVID-19 and anyone who is not living with an infected person had scored signicantly. <strong>Conclusion:</strong> In this study, we disclosed a high prevalence of depression, anxiety and stress during the COVID-19 pandemic in Saudi Arabia. In conclusion, COVID-19 is an epidemiological crisis that is casting a shadow on vulnerable population. Appropriate knowledge and specialized interventions must be accessible to promote the psychological health of the Saudi population.</p> Ahlam Furayhan Althobaiti Shuruq Hamdan Alshalawi Atheer Atallah Alqurashi Waad Faris Altowairqi Hajer Mubark Alsulami Shaheen Sultana ##submission.copyrightStatement## 2023-03-02 2023-03-02 13 2 344 358 10.5530/ijpi.13.2.045 The Evaluation and Effectiveness of Regional Language Patient Information Leaflets for Persons with Chronic Kidney Disease <p style="text-align: justify;"><strong>Objectives: </strong>The objective of this study was to develop Chronic Kidney Disease Patient Information Leaflets (CKD-PILs) to test their understandability and assess their usefulness. <strong>Materials and Methods:</strong> Prospective observational research was carried out in a dialysis unit at renowned medical care for 9 months and 140 CKD patients enrolled in the study to evaluate prepared CKD-PILs. Patient Information Leaflets (PILs) is prepared by referring to various medical database and it’s evaluated using computer-aided readability tools using the website “http://r”. Afterward, PIL was translated into a regional language and verified by a subject expert. The design and layout were analyzed using BADL criteria and user option tests.<strong> Results: </strong>Prepared CKD-PILs found to be good design and layout as per BALD and user opinion (BALD Assamese: 27, BALD English: 28; User opinion: 82.7% for Assamese PILs and 89.2% for English PILs). The mean scores on the knowledge evaluated using user testing methods and Disease management and lifestyle-related knowledge increased from 49.08±4.16 to 80.40±5.71 (<em>p</em>&lt;0.001) and is statistically significant.<strong> Conclusion: </strong>The results showed significant improvement of their lifestyle and disease-related knowledge after the implementation of PILs. The Prepared CKD-based patient information leaflets have been found to be a good and effective educational tool for CKD patients.</p> Ruhul Amin Biplab Kumar Dey Faruk Alam ##submission.copyrightStatement## 2023-03-06 2023-03-06 13 2 359 366 10.5530/ijpi.13.2.046