title: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for simultaneous determination of tenofovir and emtricitabine in human plasma and its application to a bioequivalence study.
abstract: A rapid and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for simultaneous quantification of Tenofovir (TEN) and Emtricitabine (EMT) in human plasma using Chromolith Speed Rod RP18. The mass transition ion-pair has been followed as m/z 288.10-->176.10 for TEN, m/z 248.20-->130.20 for EMT and m/z 230.10-->112.10 for Lamivudine (LAM). The method involves solid phase extraction from plasma, simple isocratic chromatographic conditions and mass spectrometric detection using an API 5000 instrument that enables detection at nanogram levels. Lamivudine was used as the internal standard. The proposed method has been validated with a linear range of 10-600 ng/ml for TEN and 25-2,500 ng/ml for EMT. The intrarun and interrun precision values are within 12.0% for TEN and 15.6% for EMT at their respective LOQ levels. The overall recoveries for TEN and EMT were 84.3% and 68.5%, respectively. Total elution time was as low as 2 min.
authors.affiliation: Department of Chemistry, Ramnarain Ruia College, Mumbai University, Matunga, Mumbai 400 019, India. noel.gomes@accutestindia.com
authors.forename: Noel A
authors.initials: NA
authors.lastname: Gomes
authors.forename: Vikas V
authors.initials: VV
authors.lastname: Vaidya
authors.forename: Ashutosh
authors.initials: A
authors.lastname: Pudage
authors.forename: Santosh S
authors.initials: SS
authors.lastname: Joshi
authors.forename: Sagar A
authors.initials: SA
authors.lastname: Parekh
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000097:blood; D002138:Calibration; D002853:Chromatography, Liquid / Q000379:methods*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000097:blood; D004338:Drug Combinations; D004355:Drug Stability; D000068679:Emtricitabine; D006801:Humans; D063065:Organophosphonates / Q000097:blood*; D017410:Practice Guidelines as Topic / Q000592:standards; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D018894:Reverse Transcriptase Inhibitors / Q000097:blood*; D012680:Sensitivity and Specificity; D013607:Tablets / Q000032:analysis; D053719:Tandem Mass Spectrometry / Q000379:methods*; D000068698:Tenofovir; D013810:Therapeutic Equivalency; D013997:Time Factors
chemical_list: D004338:Drug Combinations; D063065:Organophosphonates; D018894:Reverse Transcriptase Inhibitors; D013607:Tablets; D003841:Deoxycytidine; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine