A Stability Indicating Validated Method for the Determination of Lercanidipine Using Reverse Phase High Performance Liquid Chromatography

  • Sumanta Mondal Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.
  • Reddipalli Pushpalatha Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.
  • Prasenjit Mondal Vaageswari Institute of Pharmaceutical sciences, Ramakrishna Colony, Karimnagar, Telangana, INDIA.
  • Ashes Sinha Mahapatra Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.
  • Dipankar Shit Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.
  • Anik Kumar Das Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.
  • Sabyasachi Biswal Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.
Keywords: Lercanidipine, HPLC, Method development, ICH guidelines, Validation

Abstract

Objective: An accurate reverse phase High Performance liquid chromatography (RP-HPLC) method has been developed, validated and applied to stability indicating studies to determine Lercanidipine HCl in dosage form. Methods: Optimized chromatographic conditions were achieved by using Symmetry C18 Column, 250 mmx4.6 mm and 5μm particle size as stationary phase and Dihydrogen Orthophosphate Buffer: Methanol: ACN = (40 : 40 : 20) as eluent at flow rate 1.0 ml/min. UV detection was performed at 256nm. The developed method was validated and stability study was conducted as per ICH guidelines. Results: The retention time was found at 4.778 min. The method shows linearity over a range of 6 μg/ml to 40 μg /ml. The obtained correlation coefficient is 0.999. The LOD and LOQ values were 0.09 and 0.27 μg /ml. The acidic and alkaline stressed study shows more degradation of 8.181% and 7.241%. Conclusion: The present developed method was found stability indicating, easy and reliable method can be applied for routine analysis of lercanidipine in bulk drug and the Pharmaceutical formulations.

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Table 5: Results of stressed degradation study
Published
2020-06-08
How to Cite
1.
Mondal S, Pushpalatha R, Mondal P, Mahapatra A, Shit D, Das A, Biswal S. A Stability Indicating Validated Method for the Determination of Lercanidipine Using Reverse Phase High Performance Liquid Chromatography. ijpi [Internet]. 8Jun.2020 [cited 30Oct.2020];10(2):197-01. Available from: http://www.jpionline.org/index.php/ijpi/article/view/522