Determination of doravirine in human plasma using liquid–liquid extraction and HPLC

Determination of doravirine in human plasma using liquid–liquid extraction and HPLC–MS/MS

Published:2019-08 Issue:16 Volume:11 Page:1495-1508
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Desai Rajesh¹,Roadcap Brad¹,Goykhman Dina¹,Woolf Eric¹

Affiliation:

1. Department of Pharmacokinetics, Pharmacodynamics & Drug Metabolism, MRL, Merck & Co., Inc., West Point, PA 19486-0004, USA

Abstract

Aim: A method to quantitate doravirine (MK-1439) in human plasma has been developed to support human clinical trials designed to evaluate the safety, pharmacokinetics and efficacy of the compound. Methodology & results: The analyte was extracted using liquid–liquid extraction, separated on a reverse phase HPLC column, and detected on an API-4000 mass spectrometer using a Turbo-Ion spray source in positive ionization mode coupled with multiple reaction monitoring mode was used for quantification. The dynamic range for the assay was 0.02–10 ng/ml using 100 μl of human plasma. Conclusion: The assay was found to be sensitive, selective and reproducible and applied to support the doravirine clinical development program.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

https://www.future-science.com/doi/pdf/10.4155/bio-2019-0116

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4. Doravirine Suppresses Common Nonnucleoside Reverse Transcriptase Inhibitor-Associated Mutants at Clinically Relevant Concentrations

5. A randomized, double-blind, placebo-controlled, short-term monotherapy study of doravirine in treatment-naive HIV-infected individuals

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