Development and validation of a simple, selective, and sensitive LC-MS/MS assay for the quantification of remdesivir in human plasma.
J Chromatogr B Analyt Technol Biomed Life Sci
; 1171: 122641, 2021 May 01.
Article
in English
| MEDLINE | ID: covidwho-1126911
ABSTRACT
Remdesivir, formerly GS-5734, has recently become the first antiviral drug approved by the U.S. Food and Drug Administration (FDA) to treat COVID-19, the disease caused by SARS-CoV-2. Therapeutic dosing and pharmacokinetic studies require a simple, sensitive, and selective validated assay to quantify drug concentrations in clinical samples. Therefore, we developed a rapid and sensitive LC-MS/MS assay for the quantification of remdesivir in human plasma with its deuterium-labeled analog, remdesivir-2H5, as the internal standard. Chromatographic separation was achieved on a Phenomenex® Synergi™ HPLC Fusion-RP (100 × 2 mm, 4 µm) column by gradient elution. Excellent accuracy and precision (<5.2% within-run variations and. <9.8% between-run variations) were obtained over the range of 0.5-5000 ng/mL. The assay met the FDA Bioanalytical Guidelines for selectivity and specificity, and low inter-matrix lot variability (<2.7%) was observed for extraction efficiency (77%) and matrix effect (123%) studies. Further, stability tests showed that the analyte does not degrade under working conditions, nor during freezing and thawing processes.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Antiviral Agents
/
Adenosine Monophosphate
/
Drug Monitoring
/
Alanine
/
Tandem Mass Spectrometry
/
COVID-19 Drug Treatment
Type of study:
Diagnostic study
/
Prognostic study
Limits:
Female
/
Humans
/
Male
Language:
English
Journal:
J Chromatogr B Analyt Technol Biomed Life Sci
Journal subject:
Biomedical Engineering
Year:
2021
Document Type:
Article
Affiliation country:
J.jchromb.2021.122641
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