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

Content Provider	PubMed Central
Author	Prabhune, Swarup Suresh Shankar, Jaguste Rajendra Laxman, Kondalkar Prakash Pradhan, Nitin Sharadchandra
Copyright Year	2014
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.
Related Links	http://dx.doi.org/10.3797/scipharm.1403-25
Ending Page	785
Page Count	9
Starting Page	777
File Format	PDF
ISSN	00368709
e-ISSN	22180532
Journal	Scientia Pharmaceutica
Issue Number	4
Volume Number	82
Language	English
Publisher	Scientia Pharmaceutica
Publisher Date	2014-01-01
Access Restriction	Open
Rights Holder	Scientia Pharmaceutica
Subject Keyword	Pharmaceutical Science Research in Higher Education
Content Type	Text
Resource Type	Article
Subject	Pharmaceutical Science

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