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Research Article Open access CC BY 4.0

A Novel Ultra Performance Liquid Chromatographic Method for the Estimation of Lercanidipine in Bulk and Tablet Dosage Form

Satyabrata Sahu, U. Sunila Kumar Patra, Pratap Kumar Patra

Journal of Pharmaceutical Research International · pp. 768–776 · Published 16 Dec 2021

10.9734/jpri/2021/v33i59A34327

Abstract

Aim: In this present study an accurate reverse phase ultra-performance liquid chromatography (RP-UPLC) method has been developed, validated and applied to stability indicating studies to determine Lercanidipine HCL in bulk and marketed dosage form. Methods: Optimized chromatographic conditions were achieved by using Waters Acquity BEH C18 (2.1 x 50mm, 1.7m) UPLC column. Empower 2 is a software, dihydrogen Orthophosphate Buffer : Methanol (40 : 60)  as eluent at flow rate 0.3 ml/min. PDA detection was performed at 254nm. Results: The developed method was validated and stability study was conducted as per ICH guidelines. The retention time was found at 0.503 min. The method shows linearity over a range of 1 μg/ml to 60 μg /ml with the obtained correlation coefficient is 0.999. The LOD and LOQ values were found 0.025 and 0.05 μg /ml. The acidic and peroxide stressed study shows more degradation of 6.23% and 3.03%. Conclusion: The present developed method was found stability indicating, reliable, validated method was applied for the routine analysis of lercanidipine in bulk drug and the pharmaceutical formulations.

Lercanidipine UPLC method development ICH guidelines stability study

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