Volume 5, Issue 1, March 2020, Page: 1-7
Development and Validation of an New High Performance Liquid Chromatography Method for Determination of Apixaban Isomers
Amit Gosar, Analytical Research & Development Department, Indoco Remedies Limited, Navi Mumbai, India
Rajendra Phadke, Analytical Research & Development Department, Indoco Remedies Limited, Navi Mumbai, India
Deepesh Patil, Analytical Research & Development Department, Indoco Remedies Limited, Navi Mumbai, India
Kushal Gupta, Analytical Research & Development Department, Indoco Remedies Limited, Navi Mumbai, India
Prasad Thakur, Analytical Research & Development Department, Indoco Remedies Limited, Navi Mumbai, India
Received: Oct. 14, 2019;       Accepted: Oct. 31, 2019;       Published: Jan. 4, 2020
DOI: 10.11648/j.cbe.20200501.11      View  26      Downloads  9
Abstract
The purpose of this research study is to develop a novel, simple, precise, accurate and economical method for determination of Apixaban API isomers. Apixaban API has three isomer as ortho, meta and para. In reverse phase and normal phase chromatography it was very difficult to separate these isomer; hence new chiral technique was adopted. This chromatographic method was developed on chiralpak IA column (250×4.6×5µm) with isocritic technique. The detection of isomeric impurities were observed at wavelength 290nm. This analytical method was validated as per ICH guideline and regression analysis showed R value (correlation coefficient) > 0.999 for Apixaban API and its isomeric impurities. A solution of Apixaban in dichloromethane was found stable up to 48 hrs. The degradation study was done within the given guidelines prescribed by ICH. The method is validated for Linearity, Accuracy and Precision.
Keywords
Apixaban, NP-HPLC, Isocritic, Validation, Chiralpak IA Column
To cite this article
Amit Gosar, Rajendra Phadke, Deepesh Patil, Kushal Gupta, Prasad Thakur, Development and Validation of an New High Performance Liquid Chromatography Method for Determination of Apixaban Isomers, Chemical and Biomolecular Engineering. Vol. 5, No. 1, 2020, pp. 1-7. doi: 10.11648/j.cbe.20200501.11
Copyright
Copyright © 2020 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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