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

Dr. Gampa Vijay Kumar¹, Dr. D. Naresh² S. Prasanna Bharathi^3
1Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
²KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
³KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

ABSTRACT
New method was established for simultaneous estimation of Bempedoic acid  and Ezetimibe by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Bempedoic acid  and Ezetimibe by using ACE C18 column (4.6×150mm) 5µ, flow rate was 1.2 ml/min, mobile phase ratio was (70:30 v/v) methanol: Phosphate buffer pH 3 (pH was adjusted with orthophosphoric acid), detection wavelength was 240nm. The instrument used was Shimadzu, model No. SPD-20MA LC+20AD, Software- LC-20 Solution. The retention times were found to be 2.733 mins and 3.415 mins. The % purity of Bempedoic acid  and Ezetimibe was found to be 101.04% and 99.24% respectively. The system suitability parameters for Bempedoic acid  and Ezetimibe such as theoretical plates and tailing factor were found to be 4668, 1.3 and 6089 and 1.2, the resolution was found to be 6.0. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study n-Bempedoic acid  and Ezetimibe was found in concentration range of 50µg-250µg and 5µg-50µg and correlation coefficient (r²) was found to be 0.999 and 0.999, % recovery was found to be 99.56% and 99.48%, %RSD for repeatability was 0.2 and 0.2, % RSD for intermediate precision was 0.2 and 0.1 respectively. The precision study was precise, robust, and repeatable.LOD value was 3.17 and 5.68, and LOQ value was 0.0172 and 0.2125 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Bempedoic acid  and Ezetimibe in API and Pharmaceutical dosage form.
Keywords: ACE C18 column, Bempedoic acid  and Ezetimibe, RP-HPLC