Development and Validation of a Stability Indicating RP-HPLC Method for Quantitative Estimation of Apixaban in Tablet Dosage Form

Abstract

Objective: The present study aimed to develop and validate a simple, accurate, precise, and stability-indicating RP-HPLC method for the quantitative estimation of Apixaban in tablet dosage form.

Methods: Chromatographic separation was achieved using a Phenomenex ODS-3 C18 column (250 mm × 4.6 mm, 5 µm). The mobile phase consisted of Methanol (70:30 v/v) at a flow rate of

1.0 mL/min. Detection was carried out at 249 nm using a UV detector. The developed method was validated according to ICH Q2(R1) guidelines for specificity, linearity, accuracy, precision, robustness, LOD, LOQ, and system suitability.

Results: The developed method showed satisfactory chromatographic performance with good peak symmetry and acceptable retention time. Validation studies demonstrated excellent linearity, accuracy, and precision within the selected concentration range. The method was found to be robust and stability-indicating, capable of separating Apixaban from its degradation products.

Conclusion: The developed RP-HPLC method is simple, rapid, accurate, precise, and suitable for routine quality control analysis of Apixaban in pharmaceutical dosage forms.