Journal of Chemistry

Journal of Chemistry / 2011 / Article

Open Access

Volume 8 |Article ID 726385 | https://doi.org/10.1155/2011/726385

S. Venugopal, U. M. Tripathi, N. Devanna, "Validated Reverse Phase HPLC Method for the Determination of Impurities in Etoricoxib", Journal of Chemistry, vol. 8, Article ID 726385, 8 pages, 2011. https://doi.org/10.1155/2011/726385

Validated Reverse Phase HPLC Method for the Determination of Impurities in Etoricoxib

Received01 Mar 2011
Accepted27 Apr 2011

Abstract

This paper describes the development of reverse phase HPLC method for etoricoxib in the presence of impurities and degradation products generated from the forced degradation studies. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degradation of etoricoxib was observed under base and oxidation environment. The drug was found stable in other stress conditions studied. Successful separation of the drug from the process related impurities and degradation products were achieved on zorbax SB CN (250 x 4.6 mm) 5 μm particle size column using reverse phase HPLC method. The isocratic method employed with a mixture of buffer and acetonitrile in a ratio of 60:40 respectively. Disodium hydrogen orthophosphate (0.02 M) is used as buffer and pH adjusted to 7.20 with 1 N sodium hydroxide solution. The HPLC method was developed and validated with respect to linearity, accuracy, precision, specificity and ruggedness.

Copyright © 2011 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


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