Abstract
The purpose of this research study is to develop a novel, simple, precise, accurate and economical method for determination of Apixaban API isomers. Apixaban API has three isomer as ortho, meta and para. In reverse phase and normal phase chromatography it was very difficult to separate these isomer; hence new chiral technique was adopted. This chromatographic method was developed on chiralpak IA column (250×4.6×5µm) with isocritic technique. The detection of isomeric impurities were observed at wavelength 290nm. This analytical method was validated as per ICH guideline and regression analysis showed R value (correlation coefficient) > 0.999 for Apixaban API 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.
Highlights
Apixaban is chemically known as 1-(4-methoxyphenyl)-7oxo-6-[4-(2-oxopiperidin-1-yl) phenyl]-4, 5, 6, 7-tetrahydro1H-pyrazolo [3, 4-c] pyridine-3-carboxamide is a Anti coagulant drug, a direct inhibitor of factor X, used in the prevention of venous thrombo embolism
The literature survey reveals that few analytical methods have been reported for Apixaban and its related compounds including spectroscopic methods, high performance liquid chromatography (HPLC) methods [7,8,9,10,11]
Our objective is to develop and validate new normal phase HPLC method for determination of Apixaban and its isomer
Summary
Apixaban is chemically known as 1-(4-methoxyphenyl)-7oxo-6-[4-(2-oxopiperidin-1-yl) phenyl]-4, 5, 6, 7-tetrahydro1H-pyrazolo [3, 4-c] pyridine-3-carboxamide is a Anti coagulant drug, a direct inhibitor of factor X, used in the prevention of venous thrombo embolism.
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