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    A Novel Stability-Indicating HPLC-DAD Method for Determination of Favipiravir, a Potential Antiviral Drug for COVID-19 Treatment; Application to Degradation Kinetic Studies and In-Vitro Dissolution Profiling

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    Author
    Marzouk, Hoda M
    Rezk, Mamdouh R
    Gouda, Amira S
    Abdel-Megied, Ahmed M
    Date
    2021-10-15
    Journal
    Microchemical journal
    Publisher
    Elsevier B.V.
    Type
    Article
    
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    Show full item record
    See at
    https://doi.org/10.1016/j.microc.2021.106917
    http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8518200/
    Abstract
    Modern pharmaceutical analysis is paying a lot of attention to the stability of novel drug formulations as well as establishment of suitable stability-indicating approaches. In the current work, a comprehensive stability-indicating HPLC-DAD method has been developed and validated for determination of favipiravir (FAV) which is a novel and emerging antiviral option in COVID-19 treatment. The stability of FAV was examined under different stress conditions. FAV was found to be susceptible to acid, base hydrolysis and oxidative degradation. Structure elucidation of the forced degradation products was carried out using mass spectrometry (MS) operated in electrospray ionization mode. Effective separation of FAV and its induced degradation products was achieved using isocratic elution mode on Zorbax C18 column maintained at 30°C. The mobile phase used was comprised of 25.0 mM phosphate buffer (pH 3.5 ± 0.05) containing 0.1% (w/v) heptane sulphonic acid sodium salt-methanol-acetonitrile (62:28:10, by volume), delivered at flow rate of 1.0 mL/min. The diode array detector signal for FAV was monitored at 321.0 nm over a concentration range of 6.25-250.00 µg/mL. The potential mechanisms for generation of degradation products were postulated through comparison of MS1 fragmentation pattern of FAV and its degradation products. Moreover, the proposed method was also extended to study the degradation kinetics. Additionally, dissolution profiling of FAV in different media was monitored. Clearly, the suggested approach is accurate, reliable, time-saving, and cost-effective. As a result, it may be utilized for regular quality control and stability assessment of FAV in its tablet dosage form.
    Rights/Terms
    © 2021 Elsevier B.V. All rights reserved.
    Keyword
    COVID-19
    Dissolution Profiling
    Favipiravir
    HPLC-DAD
    Kinetic Study
    Mass Spectrometry
    SIAM
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/16924
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.microc.2021.106917
    Scopus Count
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    UMB Coronavirus Publications
    UMB Open Access Articles

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