Development and Validation of a RP-HPLC Method for Simultaneous Determination of Bempedoic Acid and Ezetimibe in Pharmaceutical Dosage Form.

Abstract

A new and advanced Reversed Phase High-Performance Liquid Chromatography (RP-HPLC) technique has been successfully developed for the simultaneous determination of Bempedoic Acid and Ezetimibe in pharmaceutical dosage form. The analysis utilized a Kromasil C18 column and a wavelength of 224 nm for detection. Chromatographic separation was achieved using an 80:20 ratio of Acetonitrile and water (pH 2.1 adjusted with orthophosphoric acid). The retention times for Bempedoic Acid and Ezetimibe were determined to be 7.1 min and 8 min respectively.

Extensive validation was conducted, demonstrating the linear response of Ezetimibe in the concentration range of 5-40 µg/mL and Bempedoic Acid in the range of 90-720 µg/mL. The correlation coefficients (r² values) for Ezetimibe and Bempedoic Acid were 0.9973 and 0.996, respectively, indicating a strong concentration-response relationship.

Precision assessment revealed percentage relative standard deviations (% RSD) of 0.944 for Ezetimibe and 1.326 for Bempedoic Acid. The newly developed HPLC method exhibits characteristics of simplicity, linearity, precision, accuracy, suitability, and specificity. This validated method can reliably be used for routine analysis of Bempedoic Acid and Ezetimibe in pharmaceutical formulations, ensuring consistent and dependable results."