Research Article | Volume: 4; Issue: 11, November, 2014

Chromatographic Separation and in Vitro Dissolution Assessment of Tenofovir disoproxil fumarate, Emtricitabine and Nevirapine in a Fixed Dose Combination of Antiretrovirals

Kalpana Jayapalu Himaja Malipeddi Anbarasu Chinnasamy   

Open Access   

Published:  Nov 27, 2014

DOI: 10.7324/JAPS.2014.41113
Abstract

A rapid, economic and robust stability indicating HPLC method was developed and validated to quantify Tenofovir disoproxil Fumarate (TDF), Emtricitabine (EMT) and Nevirapine (NVP) simultaneously at single wavelength (254 nm) in order to assess the in vitro drug release profile from tablet formulations. Chromatographic separation was performed with a gradient elution of samples on a 4.6 mm x 150 mm, 5 μm, Inertsil ODS-2 column with buffered mobile phase containing solvent A (10 Mm ammonium acetate buffer, pH 4.6) and solvent B ( acetonitrile) at a flow rate of 1.0 mL/min). In dissolution studies, the sink condition was optimized based on quantitative solubility of TDF, EMT and NVP standards in different dissolution medium as recommended by USP. The proposed HPLC method and dissolution test condition were validated as per ICH guidelines. The results obtained meet the regulatory criteria thereby confirming that the method is suitable for routine quality control analysis and in vitro dissolution studies.


Keyword:     HPLC Validation Dissolution studies Tenofovir disoproxil Fumarate Emtricitabine Nevirapine.


Citation:

Kalpana Jayapalu, Himaja Malipeddi, Anbarasu Chinnasamy. Chromatographic Separation and in Vitro Dissolution Assessment of Tenofovir disoproxil fumarate, Emtricitabine and Nevirapine in a Fixed Dose Combination of Antiretrovirals. J App Pharm Sci, 2014; 4 (11): 076-080.

Copyright:The Author(s). This is an open access article distributed under the Creative Commons Attribution Non-Commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

HTML Full Text

Reference

Article Metrics

580 Absract views 5 PDF Downloads 585 Total views

   Abstract      Pdf Download

Related Search

By author names

Citiaion Alert By Google Scholar

Name Required
Email Required Invalid Email Address

Comment required