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  1. Article ; Online: Quantitative HPLC-MS/MS determination of Nuc, the active metabolite of remdesivir, and its pharmacokinetics in rat.

    Du, Ping / Wang, Guoyong / Yang, Song / Li, Pengfei / Liu, Lihong

    Analytical and bioanalytical chemistry

    2021  Volume 413, Issue 23, Page(s) 5811–5820

    Abstract: ... of the COVID-19 pandemic in December 2019. GS-441524 (Nuc) is the active metabolite of remdesivir and plays ... to determine Nuc concentrations in rat plasma samples after a one-step protein precipitation process ... a pivotal role in the clinical treatment of COVID-19. Here, a robust HPLC-MS/MS method was developed ...

    Abstract Remdesivir is a nucleotide analog prodrug that has received much attention since the outbreak of the COVID-19 pandemic in December 2019. GS-441524 (Nuc) is the active metabolite of remdesivir and plays a pivotal role in the clinical treatment of COVID-19. Here, a robust HPLC-MS/MS method was developed to determine Nuc concentrations in rat plasma samples after a one-step protein precipitation process. Chromatographic separation was accomplished on Waters XBrige C
    MeSH term(s) Adenosine/analogs & derivatives ; Adenosine/blood ; Adenosine/pharmacokinetics ; Adenosine/standards ; Adenosine Monophosphate/analogs & derivatives ; Adenosine Monophosphate/blood ; Adenosine Monophosphate/pharmacokinetics ; Adenosine Monophosphate/standards ; Alanine/analogs & derivatives ; Alanine/blood ; Alanine/pharmacokinetics ; Alanine/standards ; Animals ; Antiviral Agents/blood ; Antiviral Agents/pharmacokinetics ; Antiviral Agents/standards ; Chromatography, High Pressure Liquid/methods ; Limit of Detection ; Male ; Quality Control ; Rats ; Rats, Sprague-Dawley ; Reference Standards ; Reproducibility of Results ; Tandem Mass Spectrometry/methods
    Chemical Substances Antiviral Agents ; GS-441524 (1BQK176DT6) ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Adenosine (K72T3FS567) ; Alanine (OF5P57N2ZX)
    Language English
    Publishing date 2021-07-24
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 201093-8
    ISSN 1618-2650 ; 0016-1152 ; 0372-7920
    ISSN (online) 1618-2650
    ISSN 0016-1152 ; 0372-7920
    DOI 10.1007/s00216-021-03561-8
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  2. Article: Quantitative HPLC-MS/MS determination of Nuc, the active metabolite of remdesivir, and its pharmacokinetics in rat

    Du, Ping / Wang, Guoyong / Yang, Song / Li, Pengfei / Liu, Lihong

    Analytical and bioanalytical chemistry. 2021 Sept., v. 413, no. 23

    2021  

    Abstract: ... of the COVID-19 pandemic in December 2019. GS-441524 (Nuc) is the active metabolite of remdesivir and plays ... to determine Nuc concentrations in rat plasma samples after a one-step protein precipitation process ... 292.2 → 163.2 for Nuc and 237.1 → 194.1 for the internal standard (carbamazepine ...

    Abstract Remdesivir is a nucleotide analog prodrug that has received much attention since the outbreak of the COVID-19 pandemic in December 2019. GS-441524 (Nuc) is the active metabolite of remdesivir and plays a pivotal role in the clinical treatment of COVID-19. Here, a robust HPLC-MS/MS method was developed to determine Nuc concentrations in rat plasma samples after a one-step protein precipitation process. Chromatographic separation was accomplished on Waters XBrige C₁₈ column (50 × 2.1 mm, 3.5 μm) under gradient elution conditions. Multiple reaction monitoring transitions in electrospray positive ion mode were m/z 292.2 → 163.2 for Nuc and 237.1 → 194.1 for the internal standard (carbamazepine). The quantitative analysis method was fully validated in line with the United States Food and Drug Administration guidelines. The linearity, accuracy and precision, matrix effect, recovery, and stability results met the requirements of the guidelines. Uncertainty of measurement and incurred sample reanalysis were analyzed to further ensure the robustness and reproducibility of the method. This optimized method was successfully applied in a rat pharmacokinetics study of remdesivir (intravenously administration, 5 mg kg⁻¹). The method can act as a basis for further pharmacokinetic and clinical efficacy investigations in patients with COVID-19. Graphical abstract
    Keywords COVID-19 infection ; Food and Drug Administration ; analytical chemistry ; intravenous injection ; metabolites ; pharmacokinetics ; quantitative analysis ; rats ; uncertainty
    Language English
    Dates of publication 2021-09
    Size p. 5811-5820.
    Publishing place Springer Berlin Heidelberg
    Document type Article
    ISSN 1618-2642
    DOI 10.1007/s00216-021-03561-8
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