Development and Validation of Novel Analytical Method for the Simultaneous Estimation of Bempadoic Acid and Ezetimibe in Bulk and Pharmaceutical Dosage Form by RP-UPLC
Objectives: A selective and novel method has been optimized for the evaluation of Bempadoic Acid and Ezetimibe using RP-UPLC.
Materials and methods: The principle analytes chromatogram was run through SB C18 100 x 1.8 mm, 2 μm. Mobile Phase containing 0.01% OPA: Acetonitrile (60:40%, v/v) was pumped through column at 0.3 mL/ min flow rate. Optimized wavelength selected was 226 nm.
Results: The retention times of Bempadoic Acid and Ezetimibe were 1.865 min and 1.234 min respectively with a total run time of 5 min. The calibration curve indicates that the correlation coefficient (r2) was superior with a value of 1.000 in the linear range of 22.5-135 μg/mL for Bempadoic Acid and 1.25-7.5 μg/mL for Ezetimibe. The lower limits of quantification and detection for Bempadoic Acid and Ezetimibe were found to be 2.34 μg/mL and 0.77 μg/mL and 0.28 μg/mL and 0.09 μg/ mL, respectively.
Conclusion: The developed method was validated and applied to the bulk drug and formulation of Bempadoic Acid and Ezetimibe. All the results obtained with this method were accurate and precise.