DEVELOPMENT AND VALIDATION OF A RP - HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF BEMPEDOIC ACID & EZETIMIBE IN PURE AND PHARMACEUTICAL DOSAGE FORM

*P. Bala Krishnaiah, Y. Sowmya, Bairam Ravindar and Manjunath S. Y.

ABSTRACT

Analytical Method Development and Validation for Bempedoic acid and Ezetimibe in bulk and Combined Dosage Form by RP-HPLC. Include Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Bempedoic acid and Ezetimibe in Bulk and their Pharmaceutical dosage form. Using Waters alliance HPLC system, Quaternary gradient pump of e2695 series equipped with an auto sampler injector with 10μl is injected eluted with the mobile phase containing HSA and Acetonitrile in the ratio of 30:70 v/v which is pumped at a flow rate of 1ml/min and detected by UV detector at 225nm. The peak of Bempedoic acid and Ezetimibe was eluted at retention times of 3.246 min and 3.865 min respectively. In this proposed HPLC method for the selected drugs showed good linearity. Resultsfor the recoveries of selected drugs were found to be within limits (98 – 102 %). These indicate that the proposed method was accurate for the analysis.

Keywords: Bempedoic acid and Ezetimibe, Method Development, Validation, Accuracy, Precision.