Analytical Method Development and Validation of Simultaneous Estimation of Bempadoic Acid & Ezetimibe by RP-HPLC in Bulk and Pharmaceutical Dosage Form

A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Bempedoic acid and Ezetimibe in pharmaceutical dosage form. Chromatographic separation of Bempedoic acid and Ezetimibe was achieved on Waters Alliance-e2695 by using Waters X Terra RP-18 (250x4.6mm, 5) column and the mobile phase containing Methanol: 0.1% TEA pH-2.5/OPA in the ratio of 20:80% v/v. The flow rate was 1.0 ml/min; detection was carried out by absorption at 232nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Bempedoic acid and Ezetimibe were NLT 2000 and should not more than 2 respectively. % Relative standard deviation of peak areas of all measurements always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate & robust method for quantitative analysis of Bempedoic acid and Ezetimibe study of its stability.