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Sci. Pharm. 2014, 82(4), 777-786; doi:10.3797/scipharm.1403-25

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

Analytical Development Laboratory, Wanbury R&D center, Plot No.EL-16, Mahape, New Mumbai 400710, India
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Received: 27 March 2014 / Accepted: 22 May 2014 / Published: 22 May 2014
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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 degra-dation. 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.
Keywords: HPLC; Apixaban; Reversed phase; Stability-indicating HPLC; Apixaban; Reversed phase; Stability-indicating
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

PRABHUNE, S.S.; JAGUSTE, R.S.; KONDALKAR, P.L.; PRADHAN, N.S. Stability-Indicating High-Performance Liquid Chromatographic Determination of Apixaban in the Presence of Degradation Products. Sci. Pharm. 2014, 82, 777-786.

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