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Volume 82
Issue 4
10.3797/scipharm.1403-25
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Article

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

by
Swarup Suresh PRABHUNE
*,
Rajendra Shankar JAGUSTE
,
Prakash Laxman KONDALKAR
and
Nitin Sharadchandra PRADHAN
Analytical Development Laboratory, Wanbury R&D center, Plot No.EL-16, Mahape, New Mumbai 400710, India
*
Author to whom correspondence should be addressed.
Sci. Pharm. 2014, 82(4), 777-786; https://doi.org/10.3797/scipharm.1403-25
Submission received: 27 March 2014 / Accepted: 22 May 2014 / Published: 22 May 2014
Versions Notes

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

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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. https://doi.org/10.3797/scipharm.1403-25

AMA Style

PRABHUNE SS, JAGUSTE RS, KONDALKAR PL, PRADHAN NS. Stability-Indicating High-Performance Liquid Chromatographic Determination of Apixaban in the Presence of Degradation Products. Scientia Pharmaceutica. 2014; 82(4):777-786. https://doi.org/10.3797/scipharm.1403-25

Chicago/Turabian Style

PRABHUNE, Swarup Suresh, Rajendra Shankar JAGUSTE, Prakash Laxman KONDALKAR, and Nitin Sharadchandra PRADHAN. 2014. "Stability-Indicating High-Performance Liquid Chromatographic Determination of Apixaban in the Presence of Degradation Products" Scientia Pharmaceutica 82, no. 4: 777-786. https://doi.org/10.3797/scipharm.1403-25

APA Style

PRABHUNE, S. S., JAGUSTE, R. S., KONDALKAR, P. L., & PRADHAN, N. S. (2014). Stability-Indicating High-Performance Liquid Chromatographic Determination of Apixaban in the Presence of Degradation Products. Scientia Pharmaceutica, 82(4), 777-786. https://doi.org/10.3797/scipharm.1403-25

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