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Chemometric Approach Based on Factorial and Box-Behnken Designs for Determination of Anti Coronavirus Drug; Favipiravir in Bulk and Spiked Human Plasma by Green HPLC Method

Year 2021, , 70 - 78, 30.12.2021
https://doi.org/10.51435/turkjac.963652

Abstract

The present work describes development of robust, sensitive and green HPLC method with fluorescence detection for determination of favipiravir (FAV). Fractional factorial design was implemented for screening of different factors affecting chromatographic responses. Box-Behnken design was applied to study and optimize the most critical method parameters. The optimum chromatographic conditions obtained involved the use of 0.1% phosphoric acid solution and isopropanol in the ratio 98:2 % v/v as mobile phase at a flow rate of 0.8 mL/min and column oven temperature of 35ºC. Chromatographic analysis was performed on Eclipse plus® C18 (100 mm×4.6mm ×3.5 μm) column with fluorescence detector set at 361 nm and 432 nm for excitation and emission, respectively. A linear response was obtained over the range of 20 - 240 ng/mL with limit of detection of 2.01 ng/mL and quantitation limit of 6.11 ng/mL. The method was successfully implemented for determination of FAV in its pharmaceutical formulation with mean % recovery ± SD of 99.42 ± 0.59. Moreover, the sensitivity of the method allowed determination of FAV in spiked human plasma over a range of 40 – 240 ng/mL. The combined application of green chemistry and quality by design leads to development of robust green method.

Supporting Institution

Faculty of Pharmacy - Tanta University - Egypt

References

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  • [2] Furuta. Y., Komeno. T, Nakamura. T., Favipiravir (T-705), a broad spectrum inhibitor of viral RNA polymerase, Proc. Jpn. Acad., Ser. B, Phys. Biol. Sci. P, 2017. https://doi.org/10.2183/pjab.93.027.
  • [3] Wang. M., Cao R., Zhang. L., Yang. X., Liu.J., Xu. M., Shi. Z., Hu.Z., Zhong. W., Xiao. J. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro, Cell Res., , 2020. https://doi.org/10.1038/s41422-020-0282-0.
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  • [6] Bulduk. İ. HPLC-UV method for quantification of favipiravir in pharmaceutical formulations, Acta Chromatogr.,2020. https://doi.org/10.1556/1326.2020.00828.
  • [7] Gałuszka. A., Migaszewsk. Z., Konieczka. P.& Namieśnik. J., Analytical Eco-Scale for assessing the greenness of analytical procedures, TrAC Trend Anal.Chem, 2012. https://doi.org/10.1016/j.trac.2012.03.013.
  • [8] Gaber. Y., Törnvall. U., Kumar. M., Amin.M., and Kaul R. HPLC-EAT (Environmental Assessment Tool): A tool for profiling safety, health and environmental impacts of liquid chromatography methods, Green Chem., 2011. 10.1039/C0GC00667J.
  • [9] Candioti. L., De Zan. M., Cámara, M. , Goicoechea. H., Experimental design and multiple response optimization. Using the desirability function in analytical methods development, Talanta, 2014. https://doi.org/10.1016/j.talanta.2014.01.034.
  • [10] Orlandini. S., Pinzauti. S., Furlanetto. S., Application of quality by design to the development of analytical separation methods, Anal. Bioanal. Chem., 2013. https://doi.org/10.1007/s00216-012-6302-2.
  • [11] Habib. A., Mabrouk. M.,Hammad, S., Megahed. S., Implementation of factorial design for optimization of forced degradation conditions and development of validated stability indicating RP-HPLC method for Lidocaine hydrochloride , Der Pharma Chemica, 1981.
  • [12] Habib. A., Hammad. S., Megahed. S., Kamal. A., Innovative Quality by Design Approach for Development of Green Micellar HPLC Method for Simultaneous Determination of Atorvastatin and Amlodipine, Chromatographia, 2020. https://doi.org/10.1007/s10337-020-03937-5.
  • [13] Ye. C., Liu. J., Ren. F., Okafo. N., Design of experiment and data analysis by JMP® (SAS institute) in analytical method validation, J. Pharm. Biomed. Anal. , 2000. https://doi.org/10.1016/S0731-7085(00)00335-6.
  • [14] Megahed. S., Habib. A., Mabrouk. M., Hammad. S. , Application of Chromatographic Response Function in Development of Stability Indicating HPLC Method for Determination of Benoxinate Hydrochloride and Fluorescein Sodium Mixture Using Factorial Design, JAMPR, 2020. 10.21608/JAMPR.2020.21563.1001.
  • [15] Ferreira SC et al., Box-Behnken design: An alternative for the optimization of analytical methods, Anal. Chim. Acta, 2007. https://doi.org/10.1016/j.aca.2007.07.011.
  • [16] Rowe. R.C., Sheskey. P.J., Quinn. M.E. (2009) Handbook of Pharmaceutical Excipients, 6th Ed., Pharmaceutical Press, London, UK. [17] Nehls.C., Buonarati.M., Cape. S., Islam. R., Satterwhite.C., Briscoe. C., Hayes. R. Dinan, R., Sales, K.& Anderson, S., GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline, Bioanalysis, 2019. 10.4155/bio-2019-0207. [18] Pharmaceuticals and Medical Devices Agency: Avigan (favipiravir) Review Report (2014). https://www.pmda.go.jp/files/000210319.pdf.
Year 2021, , 70 - 78, 30.12.2021
https://doi.org/10.51435/turkjac.963652

Abstract

References

  • [1] Elfiky. A., SARS-CoV-2 RNA dependent RNA polymerase (RdRp) targeting: an in silico perspective, J. Biomol. Struct. Dyn., 2020 https://doi.org/10.1080/07391102.2020.1761882.
  • [2] Furuta. Y., Komeno. T, Nakamura. T., Favipiravir (T-705), a broad spectrum inhibitor of viral RNA polymerase, Proc. Jpn. Acad., Ser. B, Phys. Biol. Sci. P, 2017. https://doi.org/10.2183/pjab.93.027.
  • [3] Wang. M., Cao R., Zhang. L., Yang. X., Liu.J., Xu. M., Shi. Z., Hu.Z., Zhong. W., Xiao. J. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro, Cell Res., , 2020. https://doi.org/10.1038/s41422-020-0282-0.
  • [4] Cai. Q.,Yang. M., Liu. D., Chen. J., Shu. D., Xia. J., Liao. X., Gu. Y., Cai.Q., Yang. Y., Shen. C., Li. X., Peng, L., Huang, D., Zhang, J., Zhang, S., Wang, F. Liu, J., Chen , L., Chen , S., Wang . Z., Zhang. Z., Cao .R., Zhong. W., Liu. Y. & Liu. L., Experimental Treatment with Favipiravir for COVID-19: An Open-Label Control Study, Engineering, 2020. https://doi.org/10.1016/j.eng.2020.03.007.
  • [5] Guangling. F., Wenjuan. D., Yuxiao. D., Renyong. Z., Yanyan. G., Chonggang. D.& Jinrui. S. (2015) A kind of Favipiravir has the HPLC assay method of related substance, CN104914185B.
  • [6] Bulduk. İ. HPLC-UV method for quantification of favipiravir in pharmaceutical formulations, Acta Chromatogr.,2020. https://doi.org/10.1556/1326.2020.00828.
  • [7] Gałuszka. A., Migaszewsk. Z., Konieczka. P.& Namieśnik. J., Analytical Eco-Scale for assessing the greenness of analytical procedures, TrAC Trend Anal.Chem, 2012. https://doi.org/10.1016/j.trac.2012.03.013.
  • [8] Gaber. Y., Törnvall. U., Kumar. M., Amin.M., and Kaul R. HPLC-EAT (Environmental Assessment Tool): A tool for profiling safety, health and environmental impacts of liquid chromatography methods, Green Chem., 2011. 10.1039/C0GC00667J.
  • [9] Candioti. L., De Zan. M., Cámara, M. , Goicoechea. H., Experimental design and multiple response optimization. Using the desirability function in analytical methods development, Talanta, 2014. https://doi.org/10.1016/j.talanta.2014.01.034.
  • [10] Orlandini. S., Pinzauti. S., Furlanetto. S., Application of quality by design to the development of analytical separation methods, Anal. Bioanal. Chem., 2013. https://doi.org/10.1007/s00216-012-6302-2.
  • [11] Habib. A., Mabrouk. M.,Hammad, S., Megahed. S., Implementation of factorial design for optimization of forced degradation conditions and development of validated stability indicating RP-HPLC method for Lidocaine hydrochloride , Der Pharma Chemica, 1981.
  • [12] Habib. A., Hammad. S., Megahed. S., Kamal. A., Innovative Quality by Design Approach for Development of Green Micellar HPLC Method for Simultaneous Determination of Atorvastatin and Amlodipine, Chromatographia, 2020. https://doi.org/10.1007/s10337-020-03937-5.
  • [13] Ye. C., Liu. J., Ren. F., Okafo. N., Design of experiment and data analysis by JMP® (SAS institute) in analytical method validation, J. Pharm. Biomed. Anal. , 2000. https://doi.org/10.1016/S0731-7085(00)00335-6.
  • [14] Megahed. S., Habib. A., Mabrouk. M., Hammad. S. , Application of Chromatographic Response Function in Development of Stability Indicating HPLC Method for Determination of Benoxinate Hydrochloride and Fluorescein Sodium Mixture Using Factorial Design, JAMPR, 2020. 10.21608/JAMPR.2020.21563.1001.
  • [15] Ferreira SC et al., Box-Behnken design: An alternative for the optimization of analytical methods, Anal. Chim. Acta, 2007. https://doi.org/10.1016/j.aca.2007.07.011.
  • [16] Rowe. R.C., Sheskey. P.J., Quinn. M.E. (2009) Handbook of Pharmaceutical Excipients, 6th Ed., Pharmaceutical Press, London, UK. [17] Nehls.C., Buonarati.M., Cape. S., Islam. R., Satterwhite.C., Briscoe. C., Hayes. R. Dinan, R., Sales, K.& Anderson, S., GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline, Bioanalysis, 2019. 10.4155/bio-2019-0207. [18] Pharmaceuticals and Medical Devices Agency: Avigan (favipiravir) Review Report (2014). https://www.pmda.go.jp/files/000210319.pdf.
There are 16 citations in total.

Details

Primary Language English
Subjects Analytical Chemistry
Journal Section Research Articles
Authors

Safa Megahed 0000-0002-3064-3731

Ahmed Habib This is me 0000-0002-6250-4146

Sherin Hammad This is me 0000-0003-2102-1081

Amira Kamal This is me 0000-0003-4716-5139

Publication Date December 30, 2021
Submission Date July 10, 2021
Acceptance Date December 29, 2021
Published in Issue Year 2021

Cite

APA Megahed, S., Habib, A., Hammad, S., Kamal, A. (2021). Chemometric Approach Based on Factorial and Box-Behnken Designs for Determination of Anti Coronavirus Drug; Favipiravir in Bulk and Spiked Human Plasma by Green HPLC Method. Turkish Journal of Analytical Chemistry, 3(2), 70-78. https://doi.org/10.51435/turkjac.963652
AMA Megahed S, Habib A, Hammad S, Kamal A. Chemometric Approach Based on Factorial and Box-Behnken Designs for Determination of Anti Coronavirus Drug; Favipiravir in Bulk and Spiked Human Plasma by Green HPLC Method. TurkJAC. December 2021;3(2):70-78. doi:10.51435/turkjac.963652
Chicago Megahed, Safa, Ahmed Habib, Sherin Hammad, and Amira Kamal. “Chemometric Approach Based on Factorial and Box-Behnken Designs for Determination of Anti Coronavirus Drug; Favipiravir in Bulk and Spiked Human Plasma by Green HPLC Method”. Turkish Journal of Analytical Chemistry 3, no. 2 (December 2021): 70-78. https://doi.org/10.51435/turkjac.963652.
EndNote Megahed S, Habib A, Hammad S, Kamal A (December 1, 2021) Chemometric Approach Based on Factorial and Box-Behnken Designs for Determination of Anti Coronavirus Drug; Favipiravir in Bulk and Spiked Human Plasma by Green HPLC Method. Turkish Journal of Analytical Chemistry 3 2 70–78.
IEEE S. Megahed, A. Habib, S. Hammad, and A. Kamal, “Chemometric Approach Based on Factorial and Box-Behnken Designs for Determination of Anti Coronavirus Drug; Favipiravir in Bulk and Spiked Human Plasma by Green HPLC Method”, TurkJAC, vol. 3, no. 2, pp. 70–78, 2021, doi: 10.51435/turkjac.963652.
ISNAD Megahed, Safa et al. “Chemometric Approach Based on Factorial and Box-Behnken Designs for Determination of Anti Coronavirus Drug; Favipiravir in Bulk and Spiked Human Plasma by Green HPLC Method”. Turkish Journal of Analytical Chemistry 3/2 (December 2021), 70-78. https://doi.org/10.51435/turkjac.963652.
JAMA Megahed S, Habib A, Hammad S, Kamal A. Chemometric Approach Based on Factorial and Box-Behnken Designs for Determination of Anti Coronavirus Drug; Favipiravir in Bulk and Spiked Human Plasma by Green HPLC Method. TurkJAC. 2021;3:70–78.
MLA Megahed, Safa et al. “Chemometric Approach Based on Factorial and Box-Behnken Designs for Determination of Anti Coronavirus Drug; Favipiravir in Bulk and Spiked Human Plasma by Green HPLC Method”. Turkish Journal of Analytical Chemistry, vol. 3, no. 2, 2021, pp. 70-78, doi:10.51435/turkjac.963652.
Vancouver Megahed S, Habib A, Hammad S, Kamal A. Chemometric Approach Based on Factorial and Box-Behnken Designs for Determination of Anti Coronavirus Drug; Favipiravir in Bulk and Spiked Human Plasma by Green HPLC Method. TurkJAC. 2021;3(2):70-8.

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6th International Environmental Chemistry Congress (EnviroChem)

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