Ekawan Yoosakul, Polsak Teerawonganan, Charinthon Seeduang, Chutima Manamuti, Marium Duereh, Bancha Chuasuwan, Porranee Puranajoti, Busarat Karachot and Isariya Techatanawat
Government Pharmaceutical Organization, Thailand
Mahidol University, Thailand
Posters & Accepted Abstracts: Chem Sci J
Efavirenz (EFV)/Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF) formulation is a combination of antiretroviral agents which is indicated for the first-line regimen for treatment of HIV-1 infection. Several LC-MS/MS methods which developed for determine EFV/FTC/TDF in biological samples has been reported using various extraction methods. A selective, precise, accurate and reproducible Liquid Chromatography-tandem Mass Spectrometry (LC-MS/MS) assay method has been developed and validated for simultaneous determination of the human plasma concentration of EFV/FTC/TDF using Efavirenz-d5, Emtricitabine [2H3-15N] and Tenofovir-d7 as Internal Standards (IS). The analytes and ISs were extracted from human plasma via solid phase extraction method which validated as per the US FDA guidance for industry, bioanalytical method validation and the guideline on bioanalytical method validation of European Medicines Agency. The reconstituted samples were chromatographed on ACE5 CN column using gradient mobile phase system composed of 1 mM ammonium acetate buffer (pH 2.1):methanol and monitored in the positive ion mode by applying ESI probe. The calibration curves were linear (r2>0.99) over the concentration range of 50.453-6074.957 ng/mL, 50.213-3015.858 ng/mL and 10.276-806.678 ng/mL of EFV, FTC and TDF, respectively. The results of intra and inter day precision and accuracy studies were within the acceptable limits. The method was successfully applied to a bioequivalence study of EFV/FTC/TDF 600/200/300 mg tablets formulation after oral administration to 52 healthy Thai volunteers under fasting condition. The 90% confidence intervals of the least squares means ratios of the test to the reference product of AUC0-72 and Cmax of EFV and AUC0-tlast, AUC0-ΓΆΒ?Β? and Cmax of FTC and TDF were within the bioequivalence range of 80.00-125.00%.
Ekawan Yoosakul is currently working as a Researcher in Bioequivalence Study Group, Research and Development Institute, the Government Pharmaceutical Organization (GPO), Bangkok, Thailand, responsible for method development, method validation and bioanalysis in biological fluids.
Email:y.ekawan@gpo.or.th
Chemical Sciences Journal received 912 citations as per Google Scholar report
Spanish 
Chinese 
Russian 
German 
French 
Japanese 
Portuguese 
Hindi 