Analytical Method Development and Validation of Chloro Impurity and Methyl Ester Impurity by Using RP-HPLC

Authors

  • Suryanarayana Gottapu Research Scholar, School of Pharmacy, OPJS University, Churu, Rajasthan Author
  • Dr. Satyaveer Singh Research Supervisor, School of Pharmacy, OPJS University, Churu, Rajasthan Author

DOI:

https://doi.org/10.30904/j.jpbr.2020.4288

Keywords:

RP-HPLC, Method Validation, Chloro impurity, Methyl ester impurity

Abstract

A simple and precise RP-HPLC method was developed for the determination of Apixaban impurities like Chloro impurity and Methyl ester impurity. The chromatographic separation was achieved on an Zorbax Bonus RP (250 X 4.6mm) column with a mobile phase contain the gradient mixture of the solvents (Acetonitrile: water) in the ratio of 90:10(v/v). The eluted compounds were monitored at 270nm and the run time was 35mints.The method is repeatable and can be used for routine analysis of Apixaban in bulk and in pharmaceutical formulation. Hence it is more effective, sensitive and the impurities profile can be analyzed easily through this method. The development and validated RP-HPLC method is applied for identification of eluted the impurities.

Published

2020-06-27

Issue

Vol. 8 No. 01 (2020): JPBR

Section

Articles

License

Copyright (c) 2020 Author

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

How to Cite

Gottapu, S., & Singh, S. (2020). Analytical Method Development and Validation of Chloro Impurity and Methyl Ester Impurity by Using RP-HPLC. Journal of Pharmaceutical and Biological Research, 8(01), 19-23. https://doi.org/10.30904/j.jpbr.2020.4288