Abstract

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR ANTICOAGULANT DRUG APIXABAN IN APIXABAN DRUG SUBSTANCE AND DRUG PRODUCT

Shriram Pandurang Suryawanshi* and Prof. Dr. Gayatri Barabde

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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.

Keywords: Apixaban, RP-HPLC, Stability indicating, Assay, Validation, Tablets.