Development and Validation of an RP-HPLC Method for the Simultaneous Estimation of Rosuvastatin and Bempedoic acid in Pharmaceutical Dosage Forms

Abstract

This study outlines the successful development and validation of a robust reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Rosuvastatin and Bempedoic acid in pharmaceutical dosage forms. Multiple chromatographic trials were conducted to optimize key parameters including column type, mobile phase composition, and flow rate. The finalized method utilized a Thermostat ODS column (4.6×250 mm, 5 µm) with a mobile phase of 0.1% orthophosphoric acid (OPA) buffer (pH 3.5) and acetonitrile in a 30:70 v/v ratio, with detection at 240 nm. The method exhibited excellent system suitability, with acceptable retention times, resolution, peak symmetry, and theoretical plate counts, in accordance with ICH guidelines. Validation studies confirmed the method’s precision, accuracy, linearity, sensitivity, and robustness. Assay results showed drug content within acceptable limits 98.3% for Rosuvastatin and 100.3% for Bempedoic acid. Linearity was established over the ranges of 8–40 µg/ml and 36–180 µg/ml for Rosuvastatin and Bempedoic acid, respectively, with correlation coefficients exceeding 0.999. The method demonstrated high repeatability and intermediate precision (%RSD < 2%), while robustness testing revealed no significant impact from minor variations in flow rate and mobile phase composition. These findings affirm the method’s reliability and suitability for routine quality control of combined formulations containing Rosuvastatin and Bempedoic acid.