Journal ArticleDOI
Reliable LC-MS/MS assay for the estimation of rilpivirine in human plasma: application to a bioequivalence study and incurred sample reanalysis.
Reads0
Chats0
TLDR
A simple, precise, and rapid stable isotope dilution liquid chromatography-tandem mass spectrometry method has been developed and validated for the quantification of rilpivirine, a non-nucleoside reverse transcriptase inhibitor in human plasma.Abstract:
A simple, precise, and rapid stable isotope dilution liquid chromatography-tandem mass spectrometry method has been developed and validated for the quantification of rilpivirine, a non-nucleoside reverse transcriptase inhibitor in human plasma. Rilpivirine and its deuterated analogue, rilpivirine-d6, used as an internal standard (IS) were quantitatively extracted by liquid-liquid extraction with methyl-tert-butyl ether and diethyl ether solvent mixture from 50 μL plasma. The chromatography was achieved on Gemini C18 (150 × 4.6 mm, 5 µm) analytical column in a run time of 2.2 min. The precursor product ion transitions for rilpivirine (m/z 367.1 128.0) and IS (m/z 373.2 134.2) were monitored on a triple quadrupole mass spectrometer in the positive ionization mode. The linearity of the method was established in the concentration range of 0.5–200 ng/mL. The mean extraction recovery for rilpivirine (94.9%) and IS (99.9%) from spiked plasma samples was consistent and reproducible. The IS-normalized matrix factors for rilpivirine ranged from 0.98 to 1.02 across three quality controls. Bench top, freeze-thaw, wet extract, and long-term stability of rilpivirine was examined in spiked plasma samples. The application of the method was demonstrated by a bioequivalence study with 25 mg rilpivirine tablet formulation in 40 healthy subjects. The assay reproducibility was shown by reanalysis of 200 study samples and the % change in the concentration of repeat values from the original values was within ±15%. Copyright © 2014 John Wiley & Sons, Ltd.read more
Citations
More filters
Journal ArticleDOI
UPLC-MS/MS method for the simultaneous quantification of three new antiretroviral drugs, dolutegravir, elvitegravir and rilpivirine, and other thirteen antiretroviral agents plus cobicistat and ritonavir boosters in human plasma.
Marco Simiele,Alessandra Ariaudo,Amedeo De Nicolò,Fabio Favata,Martina Ferrante,Chiara Carcieri,Stefano Bonora,Giovanni Di Perri,Antonio D'Avolio +8 more
TL;DR: The UPLC–MS/MS method reported here could be used routinely to monitor plasma concentrations of antiviral drugs, including RPV, DTG and EVG, and has been tested on real‐life specimens with good results.
Journal ArticleDOI
Tandem mass spectrometry of small-molecule antiviral drugs: 1. HIV-related antivirals
TL;DR: The review provides fragmentation schemes of ca.
Journal ArticleDOI
Bio-analytical Assay Methods used in Therapeutic Drug Monitoring of Antiretroviral Drugs-A Review
Nitin Charbe,Flavia C. Zacconi,Nikhil D. Amnerkar,B. Ramesh,Murtaza M. Tambuwala,Emilo Climenti +5 more
TL;DR: HPLC has been the most widely used system irrespective of the availability of more sensitive chromatographic technique like UPLC, and this review highlights the advancement of the Chromatographic techniques beginning from the HPLC-UV to the more advanced technique likeUPLC-MS/MS.
Journal ArticleDOI
HPLC-MS method for simultaneous quantification of the antiretroviral agents rilpivirine and cabotegravir in rat plasma and tissues.
Inken K. Ramöller,Marco T.A. Abbate,Lalitkumar K. Vora,Aaron R.J. Hutton,Kelly C. Peng,Fabiana Volpe-Zanutto,Ismaiel Tekko,Kurtis Moffatt,Alejandro Javier Paredes,Helen O. McCarthy,Ryan F. Donnelly +10 more
TL;DR: In this paper , a high performance liquid chromatography method with mass spectrometry detection (HPLC-MS) was developed for simultaneous detection and quantification of rilpivirine and cabotegravir (CAB) in various biological matrices.
Journal ArticleDOI
Simultaneous quantification of (E) and (Z) isomers of rilpivirine and four degradation products in bulk and tablets by reversed-phase ultra-high-performance liquid chromatography and confirmation of all by molecular weight.
D. Mhaske,Arjun Kumbhar +1 more
TL;DR: In this paper , a reverse-phase UHPLC method was proposed for the simultaneous separation and quantification of (E) and (Z) isomers of rilpivirine, including two amide impurities, one nitrile impurity, and one dimer impurity.
References
More filters
Journal ArticleDOI
Validation of a rapid and sensitive high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) assay for the simultaneous determination of existing and new antiretroviral compounds.
Laura Else,Victoria Watson,Victoria Watson,John Tjia,Andrew Hughes,Marco Siccardi,Saye Khoo,David Back +7 more
TL;DR: A simple, fast and sensitive HPLC-MS/MS method for determination of the commonly used protease inhibitors, as well as the more recent antiretrovirals, the CCR5 antagonist maraviroc and the "second generation" NNRTI etravirine and rilpivirine is described.
Journal ArticleDOI
Antivirals: past, present and future.
TL;DR: Antiviral therapy is obviously needed to control those infections that are not amenable to prophylaxis by vaccination, but is also highly desirable for those infections where vaccination has not been implemented or did not fulfill its premises for complete protection.
Journal ArticleDOI
Incurred sample reanalysis (ISR): a decisive tool in bioanalytical research
TL;DR: Five troubleshooting cases encountered in the analyses of incurred samples for bioanalytical methods developed in the laboratory for mesalamine, hydrochlorothiazide, clopidogrel, sildenafil and rabeprazole are summarized to help develop more reliable and efficient bio Analytical methods.
Journal ArticleDOI
Pharmacokinetics and drug-drug interactions of antiretrovirals: an update.
TL;DR: This review aims to summarise the pharmacokinetics and key drug-drug interaction studies for newly available antiretrovirals and those in development.
Journal ArticleDOI
Nonnucleoside Reverse Transcriptase Inhibitor Resistance and the Role of the Second-Generation Agents
TL;DR: NRTI resistance is an increasing problem that may impair the chances for therapeutic success in HIV-infected patients and novel agents such as etravirine and rilpivirine provide new, sensitive options for patients and significantly improve the rate of virologic suppression when appropriately applied.