Synchronized Analysis of Bempedoic Acid and Ezetimibe in Pure Binary Mixture and Their Combined Tablets by a New Stability Indicating RP-UPLC Method

The primary purpose of the designed study was to develop and validate a commercial, insightful, precise and simple RP-UPLC approach with greater response for the synchronized investigation of Bempedoic acid and Ezetimibein pure form and their fixed-dose combination tablet form. A method with Phenyl XBD (100 x 2.1mm, 1.7mm) column, mobile (solvent) phase of 0.1% v/v TFA in water and acetonitrile in 60:40 v/v pumped with a flow of 0.4mL/min and a wavelength of 236nm were competently separate the BPA and EZM with excellent resolution and shorter RT about 0.43min and 0.86 min for BPA and EZM respectively.The R2 for a range of concentrations stated for the Bempedoic acid (20-120µg/mL) and Ezetimibe (1-6µg/mL) were 0.999 and 0.999 correspondingly. The LOD and LOQ values of Bempedoic acid (0.41µg/mL and 1.23µg/mL) and Ezetimibe (0.02 µg/mL and 0.07µg/mL) unveiled the sensitivity of the stated method. The method has been validated in compliance with ICH standards. Identification of degradants peaks accompanyingthe intended analyte peaks with acceptable resolution is ascertaining the stbilitiy –indicating feature of the proposed method. Hence, the proposed approach has significant acceptance in the pharmaceutical sector.