Development and validation of an LC-MS/MS method for quantification of favipiravir in human plasma

Challenger, Elizabeth ORCID: 0000-0002-8978-6067, Penchala, Sujan Dilly, Hale, Colin, Fitzgerald, Richard, Walker, Lauren ORCID: 0000-0002-3827-4387, Reynolds, Helen ORCID: 0000-0001-7443-4520, Chiong, Justin ORCID: 0000-0001-8063-6399, Fletcher, Tom, Khoo, Saye ORCID: 0000-0002-2769-0967 and Else, Laura (2023) Development and validation of an LC-MS/MS method for quantification of favipiravir in human plasma. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 233. 115436-. ISSN 0731-7085, 1873-264X

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Abstract

Favipiravir (FVP) is a broad-spectrum antiviral that selectively inhibits viral RNA-dependent RNA polymerase, first trialled for the treatment of influenza infection. It has been shown to be effective against a number of RNA virus families including arenaviruses, flaviviruses and enteroviruses. Most recently, FVP has been investigated as a potential therapeutic for severe acute respiratory syndrome coronavirus 2 infection. A liquid chromatography tandem mass spectrometry method for the quantification of FVP in human plasma has been developed and validated for use in clinical trials investigating favipiravir as treatment for coronavirus disease-2019. Samples were extracted by protein precipitation using acetonitrile, using ¹³C, ¹⁵N- Favipiravir as internal standard. Elution was performed on a Synergi Polar-RP 150 × 2.1 mm 4 µm column using a gradient mobile phase programme consisting of 0.2% formic acid in water and 0.2% formic acid in methanol. The assay was validated over the range 500-50,000 ng/mL; this method was found to be precise and accurate and recovery of FVP from the matrix was high. Stability experiments confirmed and expanded on the known stability of FVP, including under heat treatment and for a period of 10 months at - 80 °C.

Item Type:	Article
Additional Information:	Source info: JPBA-D-23-00488
Uncontrolled Keywords:	Favipiravir, Pharmacokinetics, Bioanalysis, COVID-19, SARS-CoV-2
Divisions:	Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology
Depositing User:	Symplectic Admin
Date Deposited:	25 May 2023 10:15
Last Modified:	06 Dec 2024 18:30
DOI:	10.1016/j.jpba.2023.115436
Open Access URL:	https://doi.org/10.1016/j.jpba.2023.115436
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3170676