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

Author(s): A Sai Datri*, KS Nataraj and A Lakshmana Rao


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.

image 10.4303/jdar/236190

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