Validated method for the simultaneous estimation of bempedoic acid and ezetimibein bulk and tablet formulation by RP-HPLC method

https://doi.org/10.54037/WJPS.2022.100903

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Bempedoic Acid and Ezetimibe in Tablet dosage form. Chromatogram was run through Kromosil C18 150 x 4.6 mm, 5m. Mobile phase containing kh2po4: Acetonitrile taken in the ratio 55:45 was pumped through column at a flow rate of 0.9 ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 246nm. The separation of Bempedoic Acid and Ezetimibe was done at a Retention time of 2.240 and 2.956 min Respectively. %RSD of the Bempedoic Acid and Ezetimibe were found to be 0.7and 0.4 respectively. %Recovery was obtained as 100.55% and 99.85% for Bempedoic Acid and Ezetimibe respectively. LOD, LOQ values obtained from regression equations of Bempedoic Acid and Ezetimibe were 0.25, 0.75 and 0.01, 0.05 respectively. Regression equation of Bempedoic Acid is y = 17525x + 5630.7, y = 11636x + 418.8 of Ezetimibe. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.