title: Microdetermination of emtricitabine in human plasma by liquid chromatography/tandem mass spectrometry.
abstract: A simple, precise, and rapid LC/MS/MS method was developed and validated for the quantification of emtricitabine in human plasma using lamivudine as the internal standard (IS). The method involves liquid-liquid extraction of emtricitabine and the IS in diethyl ether-ethyl acetate (50 + 50, v/v) from 0.1 mL human plasma. A Kromasil C18 (150 x 4.6 mm, 5 microm particle size) analytical column was used for the chromatographic separation under isocratic conditions. The parent --> product ion transitions for emtricitabine (m/z 248.0 --> 130.0) and the IS (m/z 230.1 --> 112.0) were monitored on a triple-quadrupole mass spectrometer, operated in the multiple reaction monitoring positive ion mode. The method was validated over the concentration range of 29.2-3110 ng/mL for emtricitabine, with a total chromatographic run time of 1.5 min. Acceptable precision and accuracy were obtained for the concentrations used to prepare the standard curves. The applicability of the method was demonstrated by a pharmacokinetic study conducted with 43 healthy volunteers who were administered a capsule formulation containing 200 mg emtricitabine.
authors.affiliation: Veeda Clinical Research, Bioanalytical Research Department, Ambawadi, Ahmedabad 3800015, India.
authors.forename: Manish
authors.initials: M
authors.lastname: Yadav
authors.forename: Puran
authors.initials: P
authors.lastname: Singhal
authors.forename: Sailendra
authors.initials: S
authors.lastname: Goswami
authors.forename: Primal
authors.initials: P
authors.lastname: Sharma
authors.forename: Pranav S
authors.initials: PS
authors.lastname: Shrivastav
mesh_terms: D019380:Anti-HIV Agents / Q000097:blood* / Q000493:pharmacokinetics; D019540:Area Under Curve; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics; D000068679:Emtricitabine; D006207:Half-Life; D006801:Humans; D007202:Indicators and Reagents; D008297:Male; D012015:Reference Standards; D015203:Reproducibility of Results; D018894:Reverse Transcriptase Inhibitors / Q000097:blood* / Q000493:pharmacokinetics; D053719:Tandem Mass Spectrometry
chemical_list: D019380:Anti-HIV Agents; D002214:Capsules; D007202:Indicators and Reagents; D018894:Reverse Transcriptase Inhibitors; D003841:Deoxycytidine; D000068679:Emtricitabine