BACKGROUND: A sensitive, specific and robust liquid chromatography-tandem mass spectrometry method has been developed and validated for the quantification of rilpivirine in human plasma, genital/rectal biofluids and mucosal tissues. METHODS: Plasma and tissue samples were extracted using protein precipitation (acetonitrile/water; 5:1 v/v), and genital/rectal biofluids absorbed onto ophthalmic swabs were extracted using liquid-liquid extraction (hexane/ethyl acetate; 80:20 v/v). A stable isotope-labeled internal standard ((13)C-d4-RPV) was used, and the assay was validated over a concentration range of 0.5-400 ng/ml. CONCLUSION: Inter- and intra-assay precision and accuracy met the acceptance as per US FDA bioanalytical guidelines. The validated assay has been used for the determination of rilpivirine concentrations in these matrices as part of an exploratory pharmacokinetic study investigating the suitability of a long-acting formulation of rilpivirine for pre-exposure prophylaxis.
BACKGROUND: A sensitive, specific and robust liquid chromatography-tandem mass spectrometry method has been developed and validated for the quantification of rilpivirine in human plasma, genital/rectal biofluids and mucosal tissues. METHODS: Plasma and tissue samples were extracted using protein precipitation (acetonitrile/water; 5:1 v/v), and genital/rectal biofluids absorbed onto ophthalmic swabs were extracted using liquid-liquid extraction (hexane/ethyl acetate; 80:20 v/v). A stable isotope-labeled internal standard ((13)C-d4-RPV) was used, and the assay was validated over a concentration range of 0.5-400 ng/ml. CONCLUSION: Inter- and intra-assay precision and accuracy met the acceptance as per US FDA bioanalytical guidelines. The validated assay has been used for the determination of rilpivirine concentrations in these matrices as part of an exploratory pharmacokinetic study investigating the suitability of a long-acting formulation of rilpivirine for pre-exposure prophylaxis.
Authors: Charlene S Dezzutti; Laura J Else; Sarah E Yandura; Cory Shetler; Julie Russo; David J Back; Ian McGowan Journal: Antimicrob Agents Chemother Date: 2016-04-22 Impact factor: 5.191
Authors: Ahizechukwu C Eke; Nahida Chakhtoura; Angela Kashuba; Brookie M Best; Craig Sykes; Jiajia Wang; Alice M Stek; Elizabeth Smith; Samantha Calabrese; Edmund V Capparelli; Mark Mirochnick Journal: J Acquir Immune Defic Syndr Date: 2018-07-01 Impact factor: 3.731
Authors: Panita Maturavongsadit; Roopali Shrivastava; Craig Sykes; Mackenzie L Cottrell; Stephanie A Montgomery; Angela D M Kashuba; S Rahima Benhabbour Journal: Int J Pharm Date: 2021-07-01 Impact factor: 6.510
Authors: Maelíosa T C Mc Crudden; Eneko Larrañeta; Annie Clark; Courtney Jarrahian; Annie Rein-Weston; Sophie Lachau-Durand; Nico Niemeijer; Peter Williams; Clement Haeck; Helen O McCarthy; Darin Zehrung; Ryan F Donnelly Journal: J Control Release Date: 2018-11-02 Impact factor: 9.776