DEVELOPMENT AND VALIDATION OF A ROBUST RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF BEMPEDOIC ACID AND EZETIMIBE IN PHARMACEUTICAL DOSAGE FORMS

Abstract

A robust, accurate, and reproducible reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous quantification of Bempedoic Acid and Ezetimibe in tablet dosage forms. Chromatographic separation was achieved using an Inertsil ODS C18 column (150 × 4.6 mm, 5 μm particle size) with a mobile phase composed of phosphate buffer (pH 4.7) and acetonitrile in the ratio of 70:30 v/v. The mobile phase was delivered at a flow rate of 1.0 mL/min and detection was carried out at 234 nm. The retention times were 2.3 min and 3.7 min for Bempedoic Acid and Ezetimibe, respectively. The method was validated in accordance with ICH guidelines, demonstrating excellent linearity (R² = 0.999), precision (RSD < 2%), accuracy (98.88% and 99.08% recovery), and robustness. The LOD and LOQ were 1.75 μg/mL, 5.3 μg/mL for Bempedoic Acid and 0.09 μg/mL, 0.28 μg/mL for Ezetimibe. The developed method is simple, rapid, and suitable for routine quality control analysis.