title: The development and validation of an UHPLC-MS/MS method for the rapid quantification of the antiretroviral agent dapivirine in human plasma.
abstract: BACKGROUND
  Dapivirine is a non-nucleoside reverse transcriptase inhibitor designed to prevent HIV-1 viral replication and subsequent propagation. A sensitive method is required to quantify plasma concentrations to assess drug efficacy.
  
  
  RESULTS
  Dapivirine-spiked plasma was combined with acetonitrile containing deuterated IS and was processed for analysis. The method has an analytical measuring range from 20 to 10,000 pg/ml. For the LLOQ, low, mid and high QCs, intra- and inter-assay precision (%CV) ranged from 5.58 to 13.89% and 5.23 to 13.36%, respectively, and intra- and inter-day accuracy (% deviation) ranged from -5.61 to 0.75% and -4.30 to 6.24%, respectively.
  
  
  CONCLUSIONS
  A robust and sensitive LC-MS/MS assay for the high-throughput quantification of the antiretroviral drug dapivirine in human plasma was developed and validated following bioanalytical validation guidelines. The assay meets criteria for the analysis of samples from large research trials.
authors.affiliation: Division of Clinical Pharmacology, Department of Medicine, The Johns Hopkins University School of Medicine, 600 North Wolfe St, Osler 501, Baltimore, MD 21287, USA.
authors.forename: Lauren A
authors.initials: LA
authors.lastname: Seserko
authors.forename: Joshua F
authors.initials: JF
authors.lastname: Emory
authors.forename: Craig W
authors.initials: CW
authors.lastname: Hendrix
authors.forename: Mark A
authors.initials: MA
authors.lastname: Marzinke
mesh_terms: D019380:Anti-HIV Agents / Q000097:blood*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006801:Humans; D057230:Limit of Detection; D011743:Pyrimidines / Q000097:blood*; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D019380:Anti-HIV Agents; D011743:Pyrimidines; C481671:Dapivirine