Open AccessA Novel Ultra Performance Liquid Chromatographic Method for the Estimation of Lercanidipine in Bulk and Tablet Dosage Form
Author(s) -
Satyabrata Sahu,
U. Sunila Kumar Patra,
Pratap Kumar Patra
Publication year - 2021
Publication title -
journal of pharmaceutical research international
Language(s) - English
Resource type - Journals
ISSN - 2456-9119
DOI - 10.9734/jpri/2021/v33i59a34327
Subject(s) - chromatography , lercanidipine , dosage form , high performance liquid chromatography , retention time , chemistry , correlation coefficient , methanol , forced degradation , reversed phase chromatography , mathematics , medicine , statistics , organic chemistry , blood pressure , radiology
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.