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

Yıl 2021, Cilt: 3 Sayı: 2, 70 - 78, 30.12.2021

Safa Megahed , Ahmed Habib Sherin Hammad Amira Kamal

https://doi.org/10.51435/turkjac.963652

Cited By: 9

Öz

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.

Anahtar Kelimeler

Favipiravir, COVID-19 virus, Box-Behnken design, Green chemistry, Human plasma

Destekleyen Kurum

Faculty of Pharmacy - Tanta University - Egypt

Kaynakça

• [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.