RP- HPLC Analytical Method Development and Validation for the Simultaneous Estimation of Bempedoic Acid and Ezetimibe in Bulk and Tablet Dosage Form

A simple, Accurate, precise method was developed for the simultaneous estimation of the Bempedoic acid and Ezetimibe in bulk and tablet dosage form.(1) Chromatogram was run through Kromosil C18 150 x 4.6 mm, 3.0m. Mobile phase containing 0.01N Kh2Po4 Buffer: Methanol taken in the ratio 70:30 was pumped through the column at a flow rate of 0.9ml/min. The buffer used in this method was 0.01N Kh2Po4 buffer. Temperature was maintained at 30°C. The optimized wavelength selected was 260.0 nm. The retention time of Bempedoic acid and Ezetimibe was found to be 2.780min and 2.123min. %RSD of the Bempedoic acid and Ezetimibe were found to be 0.6 and 1.3 respectively. % Recovery was obtained as 99.87% and 100.12% for Bempedoic acid and Ezetimibe respectively. LOQ, and LOD values obtained from regression equations of Bempedoic acid and Ezetimibe were 0.10, 0.35, and 0.01, 0.03 respectively. The regression equation of Bempedoic acid is y = 28262x + 4418.6, and y = 28796x + 190.13 of Ezetimibe. Retention times were decreased and that run time was decreased, so the method developed was simple and economical and can be adopted in regular Quality control tests in Industries.