Table of Contents
ISRN Chromatography
Volume 2013, Article ID 878295, 8 pages
http://dx.doi.org/10.1155/2013/878295
Research Article

A Validated Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Tenofovir, Emtricitabine, and a Efavirenz and Statistical Approach to Determine the Effect of Variables

1National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad 500037, India
2USP-India Private Limited, ICICI Knowledge Park, Shameerpet, Hyderabad 500078, India

Received 30 November 2012; Accepted 26 December 2012

Academic Editors: C. Akbay, G. K. Jayaprakasha, and C. M. Remsberg

Copyright © 2013 Prashant S. Devrukhakar et al. 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.

Abstract

A simple, rapid, and stability-indicating RP-HPLC method for a combination of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and efavirenz (EFV) was developed and validated with the help of a suitable statistical software as an application tool for the quality by design. The drugs individually, and in combination, were subjected to forced degradation (thermal, photolytic, hydrolytic, and oxidative stress conditions) and accelerated stability studies (40 ± 1°C/75 ± 3% RH for three months). Successful separation of combined drugs from degradation products was achieved by gradient elution on a reverse-phase C18 column, using a mobile phase containing phosphate buffer (pH 3.5): acetonitrile at 1.5 mL min−1 flow rate, detection wavelength 256 nm, column oven temperature 25°C, and injection volume 10 μL. Linearity was established in the range of 20–300 μg mL−1, 24.5–367.5 μg mL−1 and 60–900 μg mL−1 for FTC, TDF, and EFV, respectively. The method was successfully applied for quantifying the drugs in marketed dosage forms and on stability samples.