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.
| Published in | Chemical and Biomolecular Engineering (Volume 5, Issue 1) |
| DOI | 10.11648/j.cbe.20200501.11 |
| Page(s) | 1-7 |
| Creative Commons |
This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited. |
| Copyright |
Copyright © The Author(s), 2020. Published by Science Publishing Group |
Apixaban, NP-HPLC, Isocritic, Validation, Chiralpak IA Column
| [1] | Indian Pharmacopoeia, volume III, Ministry of Health and Family Welfare Government of India. Published by Indian Pharmacopoeia Commission, Ghaziabad, 2014. |
| [2] | The British Pharmacopoeia, the British Pharmacopoeia Commission, London. 2012; Vol. II. |
| [3] | The United state Pharmacopoeia, the United state Pharmacopoeia Commission, America. 2012. |
| [4] | ICH Harmonized Tripartite Guideline, Validation of analytical procedure text and methodology Q2 [R1]. In International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use, 2005. |
| [5] | AM K, Vidhate MB, Ingale MR. Analytical method development and validation for estimation of apixaban by RP-HPLC. Indian Drugs, 2017; Vol. 54 (4); 76-79. |
| [6] | Sun YY, Zhao YL, Duan MM, Wang DK, Yu ZG. Determination of related substances in apixaban by HPLC. Journal of Shenyang Pharmaceutical University. 2017 (1): 7. |
| [7] | Mahendra B, Sundari KH, Vimalakkannan T. Method developed for the determination of apixaban by using UV spectrophotometric. International Journal of Research In Pharmaceutical Chemistry and Analysis. 2019 Jul 29; 1 (3): 83-7. |
| [8] | El-Bagary RI, Elkady EF, Farid NA, Youssef NF. Validated spectrofluorimetric methods for the determination of apixaban and tirofiban hydrochloride in pharmaceutical formulations. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 2017 Mar 5; 174: 326-30. |
| [9] | Bhavesh R. Sharma Chainesh N. Shah, A Recent Research Review- Development and Validation with liquid chromatography, J Pharm Sci Bioscientific Res. 2016. 6 (5): 723-727. |
| [10] | Rajan ST, Eswaraiah S, Venkatesh M, inventors; Msn Laboratories Limited, assignee. Intermediate and polymorphs of 1-(4-methoxypheny1)-7-oxo-6-[4-(2-oxopiperidin-1-yl) phenyl]-4, 5, 6, 7-tetra hydro-1H-pyrazolo [3, 4-c] pyridine-3-carboxamide and process thereof. United States patent US 9,718,779. 2017 Aug 1. |
| [11] | Vemula Archana Reddy, Method development and validation of apixaban in bulk and tablet dosage form by RP-HPLC. Journal of Pharmacreations Vol-5 (1) 2018 [01-24] |
| [12] | D. Shravan Kumar, Dr. M. Ajitha, Mahesh Rajendra Awate, K. S. L. Harika, stability indicating assay method development and validation of apixaban tablets by RP-HPLC. J Sci Res Pharm, 2017; 6 (Suppl 1): 71-75. |
APA Style
Amit Gosar, Rajendra Phadke, Deepesh Patil, Kushal Gupta, Prasad Thakur. (2020). Development and Validation of an New High Performance Liquid Chromatography Method for Determination of Apixaban Isomers. Chemical and Biomolecular Engineering, 5(1), 1-7. https://doi.org/10.11648/j.cbe.20200501.11
ACS Style
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. Chem. Biomol. Eng. 2020, 5(1), 1-7. doi: 10.11648/j.cbe.20200501.11
AMA Style
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. Chem Biomol Eng. 2020;5(1):1-7. doi: 10.11648/j.cbe.20200501.11
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Download@article{10.11648/j.cbe.20200501.11,
author = {Amit Gosar and Rajendra Phadke and Deepesh Patil and Kushal Gupta and Prasad Thakur},
title = {Development and Validation of an New High Performance Liquid Chromatography Method for Determination of Apixaban Isomers},
journal = {Chemical and Biomolecular Engineering},
volume = {5},
number = {1},
pages = {1-7},
doi = {10.11648/j.cbe.20200501.11},
url = {https://doi.org/10.11648/j.cbe.20200501.11},
eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.cbe.20200501.11},
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.},
year = {2020}
}
TY - JOUR T1 - Development and Validation of an New High Performance Liquid Chromatography Method for Determination of Apixaban Isomers AU - Amit Gosar AU - Rajendra Phadke AU - Deepesh Patil AU - Kushal Gupta AU - Prasad Thakur Y1 - 2020/01/04 PY - 2020 N1 - https://doi.org/10.11648/j.cbe.20200501.11 DO - 10.11648/j.cbe.20200501.11 T2 - Chemical and Biomolecular Engineering JF - Chemical and Biomolecular Engineering JO - Chemical and Biomolecular Engineering SP - 1 EP - 7 PB - Science Publishing Group SN - 2578-8884 UR - https://doi.org/10.11648/j.cbe.20200501.11 AB - 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. VL - 5 IS - 1 ER -
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