Stability-Indicating High-Performance Liquid Chromatographic Determination of Apixaban in Presence of Degradation Products

Abstract

A simple, robust, and stability-indicating reversed-phase high-performance liquid chromatographic (HPLC) method for the analysis of apixaban and its related substances has been successfully developed. Chromatography was performed on a 250 mm × 4.6 mm, 5 μm C18 column with a gradient mixture of a phosphate buffer-methanol 60:40 (v/v) at 1.0 mL min(-1). Ultraviolet detection of apixaban was at 220 nm. The method was validated for linearity, precision, repeatability, sensitivity, and selectivity. Selectivity was validated by subjecting apixaban solution to photolytic, acidic, basic, oxidative, and thermal degradation. The peaks from the degradation products did not interfere with that from apixaban. The method was used to quantify the related substances in apixaban in the bulk drug and can be used for routine quality control purposes.