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HPLC-UV method for quantification of favipiravir in pharmaceutical formulations

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Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
Favipiravir (FVP), a pyrazine analog, has shown antiviral activity against a wide variety of viruses. It is considered to be worth further investigation as a potential candidate drug for COVID-19. It is not officially available in any pharmacopoeia. A rapid, simple, precise, accurate, and isocratic high performance liquid chromatography (HPLC) method has been developed for routine quality control of favipiravir in pharmaceutical formulations. Separation was carried out by C18 column. The mobile phase was a mixture of 50 mM potassium dihydrogen phosphate (pH 2.3) and acetonitrile (90:10, v/v) at a flow rate of 1 mL min-1. The ultraviolet (UV) detection and column temperature were 323 nm, and 30 °C, respectively. The run time was 15 min under these chromatographic conditions. Excellent linear relationship between peak area and favipiravir concentration in the range of 10–100 μg mL-1 has been observed (r2, 0.9999). Developed method has been found to be sensitive (limits of detection and quantification were 1.20 μg mL-1 and 3.60 μg mL-1, respectively), precise (the interday and intraday relative standard deviation (RSD) values for peak area and retention time were less than 0.4 and 0.2%, respectively), accurate (recovery, 99.19–100.17%), specific and robust (% RSD were less than 1.00, for system suitability parameters). Proposed method has been successfully applied for quantification of favipiravir in pharmaceutical formulations.
Słowa kluczowe
Rocznik
Strony
209--215
Opis fizyczny
Bibliogr. 12 poz., rys., tab.
Twórcy
  • Department of Chemistry, School of Health, Us¸ak University, 64200, Us¸ak, Turkey
Bibliografia
  • 1. Saber-Ayad, M.; Saleh, M. A.; Abu-Gharbieh, E. The rationale for potential pharmacotherapy of COVID-19. Pharmaceuticals 2020, 13, 96–105.
  • 2. Sohrabi, C., Alsafi, Z.;O’Neill, N.; Khan, M.; Kerwan, A.; Al-Jabir, A.; et al. World Health Organization declares global emergency: A review of the 2019 novel coronavirus (COVID-19), Int. J. Surg. 2020, 76, 71–6.
  • 3. Zhu, R. F.; Gao, R. I.; Robert, S. H.; Gao, J. P.; Yang, S. G.; Zhu, C. Systematic review of the registered clinical trials of coronavirus diseases 2019 (COVID-19), J. Transl. Med. 2020, 18, 274–9.
  • 4. Prajapat, M.; Sarma, P.; Shekhar, N.; Avti, P.; Sinha, S.; Kaur, H.; et al. Drug targets for corona virus: A systematic review. Indian J. Pharm. 2020, 52(1), 56–63.
  • 5. Dong, L.; Hu, S.; Gao, J. Discovering drugs to treat coronavirus disease 2019 (COVID-19). Drug Discov. Ther. 2020, 14(1), 58–60.
  • 6. De Clercq, E. New nucleoside analogues for the treatment of hemorrhagic fever virus infections. Chem.–Asian J. 2019, 14(22), 3962–8.
  • 7. Delang, L.; Abdelnabi, R.; Neyts, J. Favipiravir as a potential countermeasure against neglected and emerging RNA viruses. Antiviral Res. 2018, 153, 85–94.
  • 8. Chen, C.; Huang, J.; Cheng, Z.; Wu, J.; Chen, S.; Zhang, Y.; et al. Favipiravir versus arbidol for COVID-19: A randomized clinical trial, medRxiv 2020, 3, 17–20.
  • 9. China patent (CN104914185B). A kind of Favipiravir has the HPLC assay method of related substance. 21.09.2016.
  • 10. China patent (CN104914185A). HPLC method for measuring related substances in Favipiravir. 16.09.2015.
  • 11. ICH. (2005). Q2 (R1), harmonized tripartite guideline, validation of analytical procedures: text and methodology, In Proceedings of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
  • 12. Center for Drug Evaluation and Research (CDER). (1994). Reviewer Guidance: Validation of Chromatographic Methods. CMC, 3.
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-3d7a43f3-054f-4263-b42e-a3d823b0e2ad
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