QBD ASSISTED STABILITY INDICATING RP-HPLC METHOD FOR ASSAY OF BEMPEDOIC ACID AND EZETIMIBE IN FORMULATION
DOI:
https://doi.org/10.22159/ijap.2026v18i3.56528Keywords:
Bempedoic acid, Ezetimibe, Method validation, Quality by design, Validation, Central composite designAbstract
Objective: Bempedoic acid belongs to a class of drugs known as adenosine triphosphate citrate lyase inhibitors. Clinically, it's mainly prescribed for managing atherosclerotic cardiovascular disease, particularly in patients with hypercholesterolemia. Ezetimibe is a highly selective 2-azetidione derivative that works by blocking cholesterol absorption at the level of enterocytes, the cells lining the intestines. The study is to develop a Quality by Design based stability indicating RP-HPLC method for their simultaneous estimation in tablet dosage forms.
Methods: Chromatographic separation was achieved using a Zorbax SB C8 column (250 x 4.6 mm, 5 µm) under isocratic conditions. The mobile phase was a blend of two solutions: Solution A - a mixture of pH 2.5 buffer and methanol (80:20 v/v), and Solution B - a mix of acetonitrile, water, and methanol (70:20:10 v/v). These were combined in a 45:55 (v/v) ratio and mixed thoroughly. The flow rate was set at 1.2 mL/min, and detection was carried out at 215 nm for Bempedoic acid and 232 nm for Ezetimibe.
Results: The retention times were observed at 6.5 minutes for Bempedoic acid and 4.2 minutes for Ezetimibe. The Linearity was found to be 0.9999 and 0.9998 for Bempedoic acid and Ezetimibe respectively. The method is highly Precise and the Recovery was found to be 100.4%and 99.6%for Bempedoic acid and Ezetimibe respectively.
Conclusion: In conclusion, the RP-HPLC method developed using an Analytical QbD framework proved to be precise, sensitive, and highly reliable for the simultaneous estimation of Bempedoic acid and Ezetimibe in tablet formulations. The systematic evaluation of method parameters ensured optimal performance, while high recovery rates confirmed the absence of excipient interference. Validation outcomes demonstrated strong linearity, accuracy, precision, and robustness, establishing the method’s suitability for routine quality control and pharmaceutical analysis.
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