1. Academic Validation
  2. Development and validation of a simple, selective, and sensitive LC-MS/MS assay for the quantification of remdesivir in human plasma

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. 2021 May 1;1171:122641. doi: 10.1016/j.jchromb.2021.122641.
Ryan Nguyen 1 Jennifer C Goodell 1 Priya S Shankarappa 1 Sara Zimmerman 1 Tyler Yin 1 Cody J Peer 1 William D Figg 2
Affiliations

Affiliations

  • 1 Clinical Pharmacology Program, Office of the Clinical Director, National Cancer Institute, Bethesda, MD, United States.
  • 2 Clinical Pharmacology Program, Office of the Clinical Director, National Cancer Institute, Bethesda, MD, United States. Electronic address: figgw@helix.nih.gov.
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

Bioanalysis; COVID-19; Mass spectrometry; Remdesivir; SARS-CoV-2.

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