Simultaneous determination of Rosuvastatin calcium and Bempedoic acid in fixed-dose combination pharmaceutical dosage forms using RP-HPLC method

A precise, simple, and, accurate method for simultaneous estimation of Rosuvastatin calcium and Bempedoic acid was developed by Reversed phase High-Performance Liquid Chromatographic (RP-HPLC). The validation of the developed method is done as per ICH guidelines. The method was developed on Waters HPLC using a Kromasil 100-5-C18 (4.6 x 250 mm) column with a detection wavelength of 220 nm. The mobile phase consists of 0.1 % OPA in water: Acetonitrile (50:50 v/v). The retention time for Rosuvastatin calcium and Bempedoic acid was found as 5.4 and 10.7 min respectively. The linearity range was established between 10.0-100.0 mu g/ml for Rosuvastatin calcium and 45.0-450.0 mu g/ml for Bempedoic acid. The correlation coefficients (r2 values) for Rosuvastatin calcium and Bempedoic Acid were 0.9985 and 0.9988 respectively, indicating a strong concentration-response relationship. The method was found to be specific as there was no interference with the peak of Rosuvastatin calcium and Bempedoic acid in presence of excipients. The % Recovery of the method was found to be 98.64%, 99.35%, and 98.27% for Rosuvastatin calcium and 99.11 %, 99.16 %, and 99.46 % for Bempedoic Acid. Therefore, the method has good trueness. Repeatability analysis of 6 samples revealed %RSD values of 0.92% and 1.41 % for Rosuvastatin calcium and Bempedoic Acid respectively. The method is precise as the mean %RSD for Intraday studies of Rosuvastatin calcium and Bempedoic acid was 0.6064% and 0.5289% respectively while the Interday studies were 0.8763 % and 0.4955 % respectively. The LOD and LOQ for Rosuvastatin calcium are 0.054 mu g/ml and 0.163 mu g/ml and for Bempedoic acid are 0.127 mu g/ml and 0.387 mu g/ml respectively. Also, the method is robust as there was no significant change in result upon changing the method parameter. The developed method is environment friendly and is suitable for the quality control analysis of Rosuvastatin calcium and Bempedoic acid either alone or in combination.