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

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

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