Stability Indicating Method Development and Validation for Anticoagulant Drug Apixaban in Apixaban Drug Substance and Drug Product

Abstract

Abstract The aimed of this research is to develop the method on reverse phase liquid chromatographic (RP-HPLC) for the assay determination of Apixaban in both drug substance and tablet dosage form. A Inertsil ODS C18 (5 μm particle size, 150 mm x 4.6 mm). was used for the RP-HPLC separation of Apixaban. The mobile phase consisted of a buffer solution pH 4 and methanol in a ratio of 50:50 v/v. The flow rate was set at 1.2 ml/minute, with an injection volume of 10 μL. The column oven temperature was maintained at 40°C, while the autosampler temperature was set to 25ºC. Detection of Apixaban was performed at a wavelength of 230 nm. The developed stability indicating analytical method underwent to validation in accordance with ICH guidelines. Results: The chromatographic condition, results showed that the peak retention time of Apixaban was 2.2 min. The linearity of Apixaban was observed in the concentration range of 7.5 µg/mL to 37.5 µg/mL, with a percent accuracy was observed in ranging from 100.0% to 101.2%. Stress testing was conducted under acidic, basic, and oxidation conditions. The linearity correlation coefficient and system suitability criteria met the requirements specified by ICH guidelines. Conclusions: The developed RP-HPLC method exhibited linearity and accuracy, with correlation coefficients and percent recovery falling within the acceptance criteria.The method proved to be simple, rapid, stability-indicating and cost-effective for the determination of Apixaban in both drug substance and tablet form.