Toxicology-Focused Development and Validation of an RP-HPLC Technique for Quantifying Bempefoic Acid and Rosuvastatin in a Fixed-Dose Combination

Abstract

A straightforward, precise method was developed to simultaneously assess Bempedoic acid and Rosuvastatin in both bulk and tablet forms. Utilizing a DIKMA Spursil C18 column (4.6 mm x 250 mm, 3.0 μm), chromatography was conducted with a mobile phase comprising 30% phosphate buffer and 70% acetonitrile, flowing at 1 ml/min. Operating at ambient temperature, the optimized wavelength for detection was set at 240 nm, revealing retention times of 4.418 min for Bempedoic acid and 3.524 min for Rosuvastatin. Both compounds exhibited high purity levels, with Bempedoic acid at 100.57% and Rosuvastatin at 100.15%. The system's suitability parameters, such as theoretical plates and tailing factor, fell within acceptable thresholds at 4402.39 and 6959.54, respectively, with values of 1.12 and 3.60.Linearity studies demonstrated strong correlation coefficients (r2) of 0.999 for both Bempedoic acid and Rosuvastatin, with mean recovery percentages of 100.33% and 100.74%, respectively. Repeatability showed low % RSD values of 1.0 and 0.3, while intermediate precision displayed % RSD values of 0.7 and 1.2, respectively. Overall, the precision study affirmed the method's reliability, robustness, and repeatability. These findings validate the proposed RP‐HPLC method as a dependable, rapid, and reproducible technique suitable for routine estimation of Bempedoic acid and Rosuvastatin in both bulk and tablet forms.