Stability-Indicating HPLC Method for the Simultaneous Determination of HIV Tablet Containing Emtricitabine, Tenofovir Disoproxil Fumarate, and Rilpivirine Hydrochloride in Pharmaceutical Dosage FormsReport as inadecuate




Stability-Indicating HPLC Method for the Simultaneous Determination of HIV Tablet Containing Emtricitabine, Tenofovir Disoproxil Fumarate, and Rilpivirine Hydrochloride in Pharmaceutical Dosage Forms - Download this document for free, or read online. Document in PDF available to download.

International Scholarly Research Notices - Volume 2014 2014, Article ID 849149, 9 pages -

Research ArticleDepartment of Pharmacy, Annamalai University, Chidambaram, Tamil Nadu 608002, India

Received 14 May 2014; Revised 18 August 2014; Accepted 20 August 2014; Published 29 October 2014

Academic Editor: Josep Esteve-Romero

Copyright © 2014 S. Venkatesan 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, accurate, rapid, and stability-indicating RP-HPLC method for a combination of tenofovir disoproxil fumarate, emtricitabine, and rilpivirine has been developed and subsequently validated in commercial tablets. The proposed HPLC method utilizes Phenomenex Gemini C18 column 150 mm × 4.6 mm i.d., 5 µm and mobile phase consisting of MeCN, potassium dihydrogen phosphate buffer 20 mM, pH 3.3, and triethylamine 58.72 : 41.23 : 0.05 v-v at a flow rate of 1.7 mL-min. Quantitation was achieved with UV detection at 270 nm. The method was validated in terms of accuracy, precision, linearity, limits of detection, limits of quantitation, and robustness. This optimized method has been successively applied to pharmaceutical formulation and no interference from the tablet excipients was found. TDF, EMT, and RPV and their combination drug product were subjected to acid, base, neutral hydrolysis, oxidation, dry heat, and photolytic stress conditions and the stressed samples were analyzed by the proposed method. As the proposed LC method could effectively separate the drugs from its degradation products, it can be employed as stability-indicating method for the determination of instability of these drugs in bulk and commercial tablets.





Author: S. Venkatesan, N. Kannappan, and Sai Sandeep Mannemala

Source: https://www.hindawi.com/



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