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Research Article

The Development and Validation of an UHPLC–MS/MS Method for The Rapid Quantification of The Antiretroviral Agent Dapivirine in Human Plasma

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Pages 2771-2783 | Published online: 21 Nov 2013

References

  • Joint United Nations Programme on HIV/AIDS. Global Report: UNAIDS Report on the Global AIDS Epidemic. Joint United Nations Programme on HIV/AIDS, Geneva, Switzerland (2012).
  • Garg AB , NuttallJ, RomanoJ. The future of HIV microbicides: challenges and opportunities. Antivir. Chem. Chemother. 19(4), 143–150 (2009)
  • Foss AM , VickermanPT, HeiseL, WattsCH. Shifts in condom use following microbicide introduction: should we be concerned? AIDS17(8), 1227–1237 (2003).
  • Akil A , ParniakMA, DezzuittiCSet al. Development and characterization of a vaginal film containing dapivirine, a non- nucleoside reverse transcriptase inhibitor (NNRTI), for prevention of HIV-1 sexual transmission. Drug Deliv. Transl. Res. 1(3), 209–222 (2011).
  • Schader SM , Colby-GerminarioSP, SchachterJR, XuH, WainbergMA. Synergy against drug-resistant HIV-1 with the microbicide antiretrovirals, dapivirine and tenofovir, in combination. AIDS25(13), 1585–1594 (2011).
  • Weber J , TatoudR, FidlerS. Postexposure prophylaxis, preexposure prophylaxis or universal test and treat: the strategic use of antiretroviral drugs to prevent HIV acquisition and transmission. AIDS24(Suppl. 4), S27–S39 (2010).
  • Cohen MS , MuessigKE, SmithMK, PowersKA, KashubaAD. Antiviral agents and HIV prevention: controversies, conflicts, and consensus. AIDS26(13), 1585–1598 (2012).
  • Van Damme L , CorneliA, AhmedKet al. Preexposure prophylaxis for HIV infection among African women. N. Engl. J. Med. 367(5), 411–422 (2012).
  • Grant RM , LamaJR, AndersonPLet al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N. Engl. J. Med. 363(27), 2587–2599 (2010).
  • Thigpen MC , KebaabetswePM, PaxtonLAet al. Antiretroviral preexposure prophylaxis or heterosexual HIV transmission in Botswana. N. Engl. J. Med. 367(5), 423–434 (2012).
  • Baeten JM , DonnellD, NdasePet al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N. Engl. J. Med. 367(5), 399–410 (2012).
  • Marrazzo JRG , NairG, PalaneeTet al. Pre-exposure prophylaxis for HIV in women: daily oral tenofovir, oral tenofovir/emtricitabine, or vaginal tenofovir gel in the VOICE (MTN 003). Programs and Abstracts of the 20th Conference on Retroviruses and Opportunistic Infections. Atlanta, GA, USA, 3–6 March 2013 (Abstract 26LB).
  • Malcolm RK , FetherstonSM, MccoyCF, BoydP, MajorI. Vaginal rings for delivery of HIV microbicides. Int. J. Womens Health4, 595–605 (2012).
  • Fetherston SM , BoydP, MccoyCFet al. A silicone elastomer vaginal ring for HIV prevention containing two microbicides with different mechanisms of action. Eur. J. Pharm. Sci. 8(3), 406–415 (2012).
  • Nuttall J , RomanoJ, DouvilleKet al. The future of HIV prevention: prospects for an effective anti-HIV microbicide. Infect. Dis. Clin. North Am. 21(1), 219–239, (2007).
  • Nel AM , CoplanP, SmytheSCet al. Pharmacokinetic assessment of dapivirine vaginal microbicide gel in healthy, HIV-negative women. AIDS Res. Hum. Retroviruses26(11), 1181–1190 (2010).
  • Nel AM , SmytheSC, HabibiS, KapturPE, RomanoJW. Pharmacokinetics of 2 dapivirine vaginal microbicide gels and their safety vs. hydroxyethyl cellulose-based universal placebo gel. J. Acquir. Immune Defic. Syndr. 55(2), 161–169 (2010).
  • Jespers VA , Van Roey JM, Beets GI, Buve AM. Dose-ranging phase 1 study of TMC120, a promising vaginal microbicide, in HIV-negative and HIV-positive female volunteers. J. Acquir. Immune Defic. Syndr. 44(2), 154–158 (2007).
  • Nel AM , CoplanP, Van De Wijgert JHet al. Safety, tolerability, and systemic absorption of dapivirine vaginal microbicide gel in healthy, HIV-negative women. AIDS23(12), 1531–1538 (2009).
  • Romano J , VarianoB, CoplanPet al. Safety and availability of dapivirine (TMC120) delivered from an intravaginal ring. AIDS Res. Hum. Retroviruses25(5), 483–488 (2009).
  • Fletcher P , HarmanS, AzijnHet al. Inhibition of human immunodeficiency virus type 1 infection by the candidate microbicide dapivirine, a nonnucleoside reverse transcriptase inhibitor. Antimicrob. Agents Chemother. 53(2), 487–495 (2009).
  • Van Herrewege Y , MichielsJ, Van RoeyJet al. In vitro evaluation of nonnucleoside reverse transcriptase inhibitors UC-781 and TMC120-R147681 as human immuno-deficiency virus microbicides. Antimicrob. Agents Chemother. 48(1), 337–339 (2004).
  • Van Herrewege Y , VanhamG, MichielsJet al. A series of diaryltriazines and diarylpyrimidines are highly potent nonnucleoside reverse transcriptase inhibitors with possible applications as microbicides. Antimicrob. Agents Chemother. 48(10), 3684–3689 (2004).
  • Di Fabio S , Van Roey J, Giannini Get al. Inhibition of vaginal transmission of HIV-1 in hu-SCID mice by the non-nucleoside reverse transcriptase inhibitor TMC120 in a gel formulation. AIDS17(11), 1597–1604 (2003).
  • Nel A , SmytheS, YoungKet al. Safety and pharmacokinetics of dapivirine delivery from matrix and reservoir intravaginal rings to HIV-negative women. J. Acquir. Immune Defic. Syndr. 51(4), 416–423 (2009).
  • Microbicides Trials Network. ASPIRE – A Study to Prevent Infection With a Ring for Extended Use. 7 October 2013.
  • das Neves J , SarmentoB, AmijiM, BahiaMF. Development and validation of a HPLC method for the assay of dapivirine in cell-based and tissue permeability experiments. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 911, 76–83 (2012)
  • das Neves J , SarmentoB, AmijiMM, BahiaMF. Development and validation of a rapid reversed-phase HPLC method for the determination of the non-nucleoside reverse transcriptase inhibitor dapivirine from polymeric nanoparticles. J. Pharm. Biomed. Anal. 52(2), 167–172 (2010).
  • US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, Center for Veterinary Medicine. Guidance for Industry: Bioanalytical Method Validation. US FDA, Rockville, MD, USA (2001).
  • The Research Foundation on Behalf of the State University of New York UaB: CPQA Guidelines for chromatographic method development and validation based on and including) FDA guidelines dated May 2001; Effective February 17, 2012. Clinical Pharmacology Quality Assurance and Quality Control version 4.0 (2012).
  • Matuszewski BK , ConstanzerML, Chavez-EngCM. Matrix effect in quantitative LC–MS/MS analyses of biological fluids: a method for determination of finasteride in human plasma at picogram per milliliter concentrations. Anal. Chem. 70(5), 882–889 (1998).
  • Nuttall JP , ThakeDC, LewisMG, FerkanyJW, RomanoJW, MitchnickMA. Concentrations of dapivirine in the rhesus macaque and rabbit following once daily intravaginal administration of a gel formulation of [14C]dapivirine for 7 days. Antimicrob. Agents Chemother. 52(3), 909–914 (2008).
  • Tarby CM . Recent advances in the development of next generation non-nucleoside reverse transcriptase inhibitors. Curr. Topics Med. Chem. 4(10), 1045–1057 (2004).

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