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Development and Validation of a Method for Quantification of Favipiravir as COVID-19 Management in Spiked Human Plasma.
Hailat, Mohammad; Al-Ani, Israa; Hamad, Mohammed; Zakareia, Zainab; Abu Dayyih, Wael.
  • Hailat M; Faculty of Pharmacy, Al-Zaytoonah University of Jordan, Amman 11733, Jordan.
  • Al-Ani I; Faculty of Pharmacy, Al-Ahliyya Amman University, Amman 19328, Jordan.
  • Hamad M; College of Science and Health Professions, King Saud Bin Abdulaziz University for Health Sciences, Jeddah 21423, Saudi Arabia.
  • Zakareia Z; Faculty of Pharmacy and Medical Sciences, University of Petra, Amman 11196, Jordan.
  • Abu Dayyih W; Faculty of Pharmacy and Medical Sciences, University of Petra, Amman 11196, Jordan.
Molecules ; 26(13)2021 Jun 22.
Article in English | MEDLINE | ID: covidwho-1288957
ABSTRACT
In the current work, a simple, economical, accurate, and precise HPLC method with UV detection was developed to quantify Favipiravir (FVIR) in spiked human plasma using acyclovir (ACVR) as an internal standard in the COVID-19 pandemic time. Both FVIR and ACVR were well separated and resolved on the C18 column using the mobile phase blend of methanolacetonitrile20 mM phosphate buffer (pH 3.1) in an isocratic mode flow rate of 1 mL/min with a proportion of 301060 %, v/v/v. The detector wavelength was set at 242 nm. Maximum recovery of FVIR and ACVR from plasma was obtained with dichloromethane (DCM) as extracting solvent. The calibration curve was found to be linear in the range of 3.1-60.0 µg/mL with regression coefficient (r2) = 0.9976. However, with acceptable r2, the calibration data's heteroscedasticity was observed, which was further reduced using weighted linear regression with weighting factor 1/x. Finally, the method was validated concerning sensitivity, accuracy (Inter and Intraday's % RE and RSD were 0.28, 0.65 and 1.00, 0.12 respectively), precision, recovery (89.99%, 89.09%, and 90.81% for LQC, MQC, and HQC, respectively), stability (% RSD for 30-day were 3.04 and 1.71 for LQC and HQC, respectively at -20 °C), and carry-over US-FDA guidance for Bioanalytical Method Validation for researchers in the COVID-19 pandemic crisis. Furthermore, there was no significant difference for selectivity when evaluated at LLOQ concentration of 3 µg/mL of FVIR and relative to the blank.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antiviral Agents / Pyrazines / Biological Assay / Chromatography, High Pressure Liquid / Liquid-Liquid Extraction / Amides / COVID-19 Limits: Humans Language: English Journal subject: Biology Year: 2021 Document Type: Article Affiliation country: Molecules26133789

Full text: Available Collection: International databases Database: MEDLINE Main subject: Antiviral Agents / Pyrazines / Biological Assay / Chromatography, High Pressure Liquid / Liquid-Liquid Extraction / Amides / COVID-19 Limits: Humans Language: English Journal subject: Biology Year: 2021 Document Type: Article Affiliation country: Molecules26133789