SIMULTANEOUS ESTIMATION OF BEMPEDOIC ACID AND EZETIMIBE BY HPLC

Abstract

The aim of the project is to develop a fast, simple, precise, and cost-efficient RP-HPLC method for measuring the amounts of Bempedoic Acid and Ezetimibe simultaneously in both pharmaceutical products and bulk samples. This technique has effectively achieved the separation of Bempedoic Acid and Ezetimibe in large quantities. The separation was performed using a Kromosil C18

150 x 4.6 mm, 5m analytical column at a wavelength of 280 nm. The mobile phase consisted of a mixture of Potassium dihydrogen orthophosphate, acetonitrile, and water in a ratio of 25:60:15. The pH of the buffer was adjusted to 6.0. The separation was carried out in isocratic elution mode with a flow rate of 1.2 ml/min. Bempedoic Acid had a retention time of 2.252 minutes, whereas Ezetimibe showed a retention duration of 2.987 minutes. Quantitative analysis of Bempedoic Acid and Ezetimibe was achieved using PDA detection at 280 nm using a linear calibration curve. The concentration ranges of 5-25 µg/ml (with a correlation coefficient of 0.9998) and 10-50 µg/ml (with a correlation coefficient of 0.9996) were used for reliable quantification. The limit of detection (LOD) for Bempedoic Acid was 0.1345 µg/ml, whereas the LOD for Ezetimibe was 0.2456 µg/ml. The proposed method is highly suitable for use in quality control laboratories for the bulk and pharmaceutical quantitative analysis of pharmaceuticals, whether used individually or in combination. This technique is characterised by its simplicity and efficiency, while yet ensuring a high level of accuracy and precision.