ABSTRACT

A novel and advanced high-performance liquid chromatography (HPLC) technique has been successfully developed for the simultaneous determination of Bempedoic Acid and Ezetimibe in both their pure form and pharmaceutical dosage forms. The separation was achieved using an Kromasil C18 column with a UV detector set at a wavelength of 224 nm. A mobile phase consisting of Acetonitrile and water (pH 2.1 adjusted with orthophosphoric acid) in a ratio of 80:20 was utilized for the chromatographic separation. The retention times for Bempedoic Acid and Ezetimibe were determined to be 7.1 min and 8 min respectively. The developed method was fully validated using various validation parameters. Ezetimibe exhibited a linear response over the concentration range of 5-40 ?g/mL, while Bempedoic Acid showed linearity in the range of 90-720 ?g/mL. The correlation coefficients (r² values) obtained for Ezetimibe and Bempedoic Acid were 0.9973 and 0.996, respectively, indicating a strong correlation between the concentration and the response. The precision of the method was also assessed, with the percentage relative standard deviations (% RSD) for Ezetimibe and Bempedoic Acid determined to be 0.944 and 1.326, respectively. The newly developed HPLC method is characterized by simplicity, linearity, precision, accuracy, suitability, and specificity. This validated method can be effectively utilized for theroutine analysis of Bempedoic Acid and Ezetimibe in pharmaceutical formulations, ensuring reliable and consistent results. Keywords: Bempedoic Acid, Ezetimibe, Correlation Coefficient, Assay, Precision
Publication date: 01/06/2025

https://ijbpas.com/pdf/2025/June/MS_IJBPAS_2025_9049.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.6.9049