Development and validation of a HPLC analytical assay method for efavirenz tablets: a medicine for HIV infections

Efavirenz is a reverse transcriptase non analog nucleoside inhibitor used to treat HIV infections. A simple assay method by high performance liquid chromatography was developed and validated for efavirenz tablets. The physical chemical characteristics of efavirenz were investigated to developing the method. The method was validated observing the parameters described in USP 29. Analyses were performed by an ultraviolet detector at a 252 nm wavelength, on a reverse-phase column (C18, 250 mm x 3.9 mm, 10 μm), using an isocratic mobile phase containing acetonitrile/water/orthophosphoric acid (70:30:0.1). The validation parameters used were: selectivity, linearity, precision, accuracy, robustness, detection and quantification limits, and all resulting data were treated by a statistical method. The results obtained confirmed an alternative assay method for efavirenz tablets adequate for routine industrial use.

Bibliographic Details

Main Authors:	Viana,Osnir de Sá, Medeiros,Flávia Patrícia Morais, Grangeiro-Júnior,Severino, Albuquerque,Miracy Muniz, Soares,Mônica Felts La Roca, Soares-Sobrinho,José Lamartine, Alves,Lariza Darlene Santos, Rolim,Larissa Araújo, Silva,Keyla Emanuelle Ramos da, Rolim-Neto,Pedro José
Format:	Digital revista
Language:	English
Published:	Universidade de São Paulo, Faculdade de Ciências Farmacêuticas 2011
Online Access:	http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502011000100012
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