Simultaneous Estimation of Bempedoic Acid and Ezetimibe by UPLC

Abstract

A selective and novel method has been optimized for the evaluation of Bempedoic Acid and Ezetimibe in bulk samples by U.P.L.C. The principle analyzes were eluted with the conditions of mobile phase having the 0.1% orthophosphoric acid and acetonitrile (90:10 ratio) using the X bridge C18 (250 × 4.6 mm, 5µm) analytical column with the 1.0 ml/min flow rate and 10 µl sample volume at 290 nm in a photodiode array detector. The retention times of Bempedoic Acid and Ezetimibe were 0.27 min and 0.73 min with the total run time of 2 min. The curve indicates the correlation coefficient (r²) was superior by having the value equal to 0.998 with a linear range of 30 n.g/m.l- 225 n.g/m.l for Bempedoic Acid and for Ezetimibe 150 n.g/m.l-1125 n.g/m.l. The correlation coefficient (r²) found linear. The LOQ and LOD for the Bempedoic Acid and Ezetimibe found 2.5 n.g/m.l and 7.5 n.g/m.l and 2.9 n.g/m.l and 8.9 n.g/m.l. After the method optimization, the method was validated as per ICH guidelines. As per the results obtained in the method validation, there was no interference of the blank and carryover problem even at the LOQ level quantification. Both LOQ and LOD of this method was verified practically in the instrument with S/N ratio criteria. The results were found satisfactory.