Method development and validation for simultaneous estimation of bempedoic acid and ezetimibe in pharmaceutical dosage form by RP- HPLC

A straight forward, accurate, and precise method has been successfully developed for the simultaneous estimation of Bempedoic acid and Ezetimibe in both bulk and tablet dosage forms. This achievement marks a significant advancement in pharmaceutical analysis. The method employed a chromatographic approach using a standard BDS C18 column measuring 150 × 4.6 mm with a particle size of 5μ. The mobile phase, comprising awell-balanced blend of 0.01N Ammonium acetate Buffer and Methanol in a 55:45 ratio, was efficiently pumped through the column at a constant flow rate of 1 ml/min. The critical buffer used in this methodology was 0.01N Ammonium acetate buffer, maintaining a stable temperature at 30°C. The optimized wavelength of 230 nm was selected for analysis. The retention times for Bempedoic acid and Ezetimibe were precisely determined as 2.219 minutes and 2.794 minutes, respectively, demonstrating the method's reproducibility with %RSD values of 0.3 and 0.4. Impressive recoveries of 100.25% for Bempedoic acid and 99.72% for Ezetimibe were achieved. Furthermore, the method exhibited impressive sensitivity with LOQ and LOD values of 0.07, 0.24, and 0.01, 0.04, respectively, derived from the regression equations. This method's exceptional efficiency not only reduced retention times but also minimized overall run time, offering a practical, cost-effective solution suitable for routine quality control testing within the pharmaceutical industry. Its simplicity and accuracy make it a valuable addition to pharmaceutical analysis techniques.