Development and Validation of an New High Performance Liquid Chromatography Method for Determination of Apixaban Isomers

Abstract

The purpose of this research study is to develop a novel, simple, precise, accurate and economical method for determination of Apixaban API isomers. This chromatographic method was developed on chiralpak IA column(250 x 4.6 x 5µm) with isocritic technique. The detection of impurities was observed at wavelength 290nm. This analytical method was validated and regression analysis showed R value (correlation coefficient) > 0.999 for Apixaban and its isomeric impurities. A solution of Apixaban in dichloromethane was found stable up to 48 hrs. The degradation study was done within the given guidelines prescribed by ICH. The method is validated for linearity, accuracy and precision.