A Stability-Indicating Ultra-Performance Liquid Chromatography Method Development and Validation for the Simultaneous Estimation of Rosuvastatin and Bempedoic Acid in Bulk and Pharmaceutical Dosage Form

Abstract

Aim: This study aimed to develop and validate a rapid, accurate, and stability-indicating ultra-performance liquid
chromatography (UPLC) method for the simultaneous estimation of Rosuvastatin and Bempedoic acid in bulk
and pharmaceutical dosage form. Materials and Methods: Chromatographic separation was achieved using an
Acquity UPLC BEH C18 column (50 mm × 1.1 mm, 1.7 µm) with a mobile phase consisting of Acetonitrile:
Ammonium formate pH-3.0/OPA in a ratio of 20:80 v/v, at a flow rate of 0.2 mL/min. Detection was carried out
at 240 nm. The method was validated in accordance with ICH Q2(R1) guidelines for system suitability, linearity,
precision, accuracy, specificity, robustness, limit of detection, and limit of quantitation. Forced degradation
studies were performed under acidic, basic, oxidative, thermal, and photolytic conditions to evaluate the stabilityindicating nature of the method. Results and Discussion: Rosuvastatin and Bempedoic acid were well resolved
with retention times of 0.627 and 1.254 min, respectively. The method demonstrated excellent linearity (r² > 0.999),
with acceptable precision (%relative standard deviation < 2%), recovery (98–102%), and robustness. Significant
degradation was observed under acid and oxidative stress, while the method successfully resolved all degradation
peaks from the analytes. Conclusion: The developed UPLC method is sensitive, reliable, and stability-indicating. It
is suitable for routine analysis and quality control of Rosuvastatin and Bempedoic acid in combined dosage forms