Determination of 19 antiretroviral agents in pharmaceuticals or suspected products with two methods using high-performance liquid chromatography.
Three classes of antiretroviral agents are usually available for the treatment of HIV infection: nucleoside reverse transcriptase inhibitors (IN), non-nucleoside reverse transcriptase inhibitors (INN) and protease inhibitors (IP). Two methods by reversed-phase liquid chromatography were developed for the analysis of 19 antiretroviral molecules belonging to these three therapeutic classes and used in medicinal products. Both of these HPLC techniques use a C18 column and UV detection. The first method is for IN family analysis and allows eight molecules to be separated: zalcitabine, lamivudine, amdoxovir, emtricitabine, didanosine, stavudine, zidovudine and abacavir. The second method is for INN and IP family analysis and allows 11 molecules to be separated: fosamprenavir, nevirapine, indinavir, amprenavir, saquinavir, atazanavir, ritonavir, lopinavir, efavirenz, nelfinavir and tipranavir. The combination of these two methods makes possible the quality control of mono-, bi- or tri-therapy pharmaceutical products and the detection of illegal products sold particularly in developing countries.
Rebiere
Hervé
H
Agence Française de Sécurité Sanitaire des Produits de Santé, Direction des Laboratoires et des Contrôles, Unité Physico Chimie 2, 635 rue de la Garenne, 34740 Vendargues, France. herve.rebiere@afssaps.sante.fr
Mazel
Bernard
B
Civade
Corinne
C
Bonnet
Pierre-Antoine
PA
D019380:Anti-HIV Agents / Q000032:analysis*; D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D019380:Anti-HIV Agents; D004364:Pharmaceutical Preparations