title: Stability-Indicating High-Performance Liquid Chromatographic Determination of Apixaban in the 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.
authors.affiliation: Analytical development laboratory, Wanbury R&D center, Plot No.EL-16, Mahape, New Mumbai 400710, India.
authors.forename: Swarup Suresh
authors.initials: SS
authors.lastname: Prabhune
authors.affiliation: Analytical development laboratory, Wanbury R&D center, Plot No.EL-16, Mahape, New Mumbai 400710, India.
authors.forename: Rajendra Shankar
authors.initials: RS
authors.lastname: Jaguste
authors.affiliation: Analytical development laboratory, Wanbury R&D center, Plot No.EL-16, Mahape, New Mumbai 400710, India.
authors.forename: Prakash Laxman
authors.initials: PL
authors.lastname: Kondalkar
authors.affiliation: Analytical development laboratory, Wanbury R&D center, Plot No.EL-16, Mahape, New Mumbai 400710, India.
authors.forename: Nitin Sharadchandra
authors.initials: NS
authors.lastname: Pradhan
keywords: Apixaban; HPLC; Reversed phase; Stability-indicating