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Development and Validation of a Method for Quantification of Favipiravir as COVID-19 Management in Spiked Human Plasma
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...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8270293/ https://www.ncbi.nlm.nih.gov/pubmed/34206357 http://dx.doi.org/10.3390/molecules26133789 |
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author | Hailat, Mohammad Al-Ani, Israa Hamad, Mohammed Zakareia, Zainab Abu Dayyih, Wael |
author_facet | Hailat, Mohammad Al-Ani, Israa Hamad, Mohammed Zakareia, Zainab Abu Dayyih, Wael |
author_sort | Hailat, Mohammad |
collection | PubMed |
description | 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 methanol:acetonitrile:20 mM phosphate buffer (pH 3.1) in an isocratic mode flow rate of 1 mL/min with a proportion of 30:10:60 %, 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 (r(2)) = 0.9976. However, with acceptable r(2), 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. |
format | Online Article Text |
id | pubmed-8270293 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-82702932021-07-10 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 Molecules Article 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 methanol:acetonitrile:20 mM phosphate buffer (pH 3.1) in an isocratic mode flow rate of 1 mL/min with a proportion of 30:10:60 %, 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 (r(2)) = 0.9976. However, with acceptable r(2), 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. MDPI 2021-06-22 /pmc/articles/PMC8270293/ /pubmed/34206357 http://dx.doi.org/10.3390/molecules26133789 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Hailat, Mohammad Al-Ani, Israa Hamad, Mohammed Zakareia, Zainab Abu Dayyih, Wael Development and Validation of a Method for Quantification of Favipiravir as COVID-19 Management in Spiked Human Plasma |
title | Development and Validation of a Method for Quantification of Favipiravir as COVID-19 Management in Spiked Human Plasma |
title_full | Development and Validation of a Method for Quantification of Favipiravir as COVID-19 Management in Spiked Human Plasma |
title_fullStr | Development and Validation of a Method for Quantification of Favipiravir as COVID-19 Management in Spiked Human Plasma |
title_full_unstemmed | Development and Validation of a Method for Quantification of Favipiravir as COVID-19 Management in Spiked Human Plasma |
title_short | Development and Validation of a Method for Quantification of Favipiravir as COVID-19 Management in Spiked Human Plasma |
title_sort | development and validation of a method for quantification of favipiravir as covid-19 management in spiked human plasma |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8270293/ https://www.ncbi.nlm.nih.gov/pubmed/34206357 http://dx.doi.org/10.3390/molecules26133789 |
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