The development and validation of an UHPLC-MS/MS method for the rapid quantification of the antiretroviral agent dapivirine in human plasma

Lauren A. Seserko, Joshua F. Emory, Craig W. Hendrix, Mark A. Marzinke

Research output: Contribution to journalArticlepeer-review

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. Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)2771-2783
Number of pages13
JournalBioanalysis
Volume5
Issue number22
DOIs
StatePublished - Nov 2013

ASJC Scopus subject areas

  • Analytical Chemistry
  • Pharmacology, Toxicology and Pharmaceutics(all)
  • Clinical Biochemistry
  • Medical Laboratory Technology

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