Details

Autor(en) / Beteiligte

• Nguyen, Ryan
• Goodell, Jennifer C.
• Shankarappa, Priya S.
• Zimmerman, Sara
• Yin, Tyler
• Peer, Cody J.
• Figg, William D.

Titel

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

Ist Teil von

• Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 2021-05, Vol.1171, p.122641-122641, Article 122641

Ort / Verlag

Netherlands: Elsevier B.V

Erscheinungsjahr

2021

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• •A fully validated HPLC-MS/MS assay for quantifying remdesivir in human plasma.•Rapid one-step solid-phase extraction was applied using an Ostro plate.•Accuracy (102-105%), precision (<9.8 CV%), and recovery (77%) met FDA Guidelines.•Lower limit of quantitation was 0.5 ng/mL. 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.