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METHOD DEVELOPMENT AND VALIDATION OF APIXABAN USING RP-HPLC METHOD AND ITS STRESS STABILITY STUDIES


Abstract

Author(s): Akiful Haque, Rayanni Soundharya, Julakanti Venu, Malipeddi Lakshmi Monika, Vasudha Bakshi

A simple, fast and precise reverse phase high performance liquid chromatographic method (RP-HPLC) good sensitivity was determined for the development and validation of Apixaban. In Water Apixaban λmax was fixed as 259nm using a Shimadzu UV-Visible spectrophotometer. The chromatographic separation was achieved on a Waters C18 column, 15μm, 4.6 x 250 mm as stationary phase with mobile phase comprising of water: Acetonitrile as a mixture in the ratio of 50:50 in an isocratic elution mode at 1.0mL/min flow rate and maintaining column temperature at ambient. The detection was monitored at 259nm for Apixaban. The retention time of Apixaban were found to be 3.4mins respectively. The linearity was found to be in the range of 5-2 μg/ml. The calibration factor is 0.999. Apixaban was subjected to photolytic, acidic, basic, oxidative, and thermal degradation. The drug was found to be stable in all the conditions. The developed method was simple, accurate, precise, specific, sensitive and reproducible. Stress testing should be given importance for quantification of degraded products of drugs helps us to maintain the quality, safety and efficacy of drugs in formulations.

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