NEW FTIR METHOD DEVELOPMENT AND VALIDATION FOR QUANTITATIVE ANALYSIS OF FAVIPIRAVIR IN BULK AND PHARMACEUTICAL DOSAGE FORMS

NITHILA P.; N. RAGHAVENDRABABU; Y. PADMAVATHI; G. NEENA; K. SUSHMA; A. POOJITHA

doi:10.22159/ijcpr.2022v14i5.2022

Authors

NITHILA P. Department of Pharmaceutical Analysis, G. Pulla Reddy College of Pharmacy, Mehdipatnam, Hyderabad, Telangana 500028
N. RAGHAVENDRABABU Department of Pharmaceutical Analysis, G. Pulla Reddy College of Pharmacy, Mehdipatnam, Hyderabad, Telangana 500028
Y. PADMAVATHI Department of Pharmaceutical Analysis, G. Pulla Reddy College of Pharmacy, Mehdipatnam, Hyderabad, Telangana 500028
G. NEENA Department of Pharmaceutical Analysis, G. Pulla Reddy College of Pharmacy, Mehdipatnam, Hyderabad, Telangana 500028
K. SUSHMA Department of Pharmaceutical Analysis, G. Pulla Reddy College of Pharmacy, Mehdipatnam, Hyderabad, Telangana 500028
A. POOJITHA Department of Pharmaceutical Analysis, G. Pulla Reddy College of Pharmacy, Mehdipatnam, Hyderabad, Telangana 500028

DOI:

https://doi.org/10.22159/ijcpr.2022v14i5.2022

Keywords:

Favipiravir, Infrared spectroscopy, Method validation, HPLC

Abstract

Objective: A simple spectrophotometric method has been proposed for quantitative analysis of favipiravir in bulk and pharmaceutical dosage form.

Methods: New Fourier transform infrared (FTIR) spectroscopic method has been developed for the estimation of favipiravir by using solid pellet technique.

Results: Results were linear over the 20–100µg/mg concentration range, with correlation values exceeding 0.999. The approach was thoroughly validated in accordance with the recommendations of the International Conference on Harmonization, demonstrating acceptable levels of accuracy, precision, selectivity, robustness, and linearity.

Conclusion: The statistical comparison between this method and HPLC revealed that the newly developed method was significantly distinct. Thus, it proves to be applicable. It met all validation standards over a variety of concentrations and can be used as a substitute for the official procedures.

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References

Rang HP, Dale MM, Ritter JM, Moore PK. Pharmacology. 5th ed. New York: Churchill Livingstone; 2003. p. 228-9.

William kemp. Organic spectroscopy. 3rd ed. New York: Palgrave publishers; 2005.

Aktas A, Tuzun B, Aslan R, Sayin K, Ataseven H. New anti-viral drugs for the treatment of COVID-19 instead of favipiravir. J Biomol Struct Dyn. 2021 Dec 12;39(18):7263-73. doi: 10.1080/07391102.2020.1806112, PMID 32783586.

Joshi S, Parkar J, Ansari A, Vora A, Talwar D, Tiwaskar M et al. Role of favipiravir in the treatment of COVID-19. Int J Infect Dis. 2021 Jan 1;102:501-8. doi: 10.1016/j.ijid.2020.10.069, PMID 33130203.

de Aragao BJ, Mosaddeq Y. Peak separation by derivative spectroscopy applied to FTIR analysis of hydrolysed silica. J Braz Chem Soc. 2008;19:1582-94.

Bulduk I. HPLC-UV method for quantification of favipiravir in pharmaceutical formulations. Acta Chromatographica. 2021 Apr 28;33(3):209-15. doi: 10.1556/1326.2020.00828.

Gallignani M, Rondon RA, Ovalles JF, Brunetto MR. Transmission FTIR derivative spectroscopy for estimation of furosemide in raw material and tablet dosage form. Acta Pharm Sin B. 2014 Oct 1;4(5):376-83. doi: 10.1016/ j.apsb.2014.06.013, PMID 26579407.

Megahed SM, Habib AA, Hammad SF, Kamal AH. Experimental design approach for the development of the spectrofluorimetric method for determination of favipiravir; a potential therapeutic agent against COVID-19 virus: application to spiked human plasma. Spectrochim Acta A Mol Biomol Spectrosc. 2021 Mar 15;249:119241. doi: 10.1016/j.saa.2020.119241, PMID 33333412.

Peng CS, Fedeles BI, Singh V, Li D, Amariuta T, Essigmann JM. Two-dimensional IR spectroscopy of the anti-HIV agent KP1212 reveals protonated and neutral tautomers that influence pH-dependent mutagenicity. Proc Natl Acad Sci USA. 2015 Mar 17;112(11):3229-34. doi: 10.1073/ pnas.1415974112, PMID 25733867.

Pandey S, Pandey P, Tiwari G, Tiwari R, Rai AK. FTIR spectroscopy: A tool for quantitative analysis of ciprofloxacin in tablets. Indian J Pharm Sci. 2012 Jan;74(1):86-90. doi: 10.4103/0250-474X.102551, PMID 23204630.

Joseph Charles J, Brault S, Boyer C, Langlois MH, Cabrero L, Dubost JP. Simultaneous determination of irbesartan and hydrochlorothiazide in tablets by derivative spectrophotometry. Anal Lett. 2003 Jan 9;36(11):2485-95. doi: 10.1081/AL-120024337.

Habler K, Brügel M, Teupser D, Liebchen U, Scharf C, Schönermarck U. Simultaneous quantification of seven repurposed COVID-19 drugs remdesivir (plus metabolite GS-441524), chloroquine, hydroxychloroquine, lopinavir, ritonavir, favipiravir and azithromycin by a two-dimensional isotope dilution LC–MS/MS method in human serum. J Pharm Biomed Anal. 2021 Mar 20;196:113935. doi: 10.1016/j.jpba.2021.113935, PMID 33548872.

Mounika PE, Padmavathi Y, Anjali AK, Reddy NP. Quantitative estimation of atorvastatin calcium in bulk and tablet dosage forms using FTIR spectroscopy. Int J Pharma Bio Sci. 2018 Apr;9(2):221-32. doi: 10.22376/ijpbs.2018.9.2.p221-232.

Nugrahani I, Musaddah M. Development and validation analysis of acyclovir tablet content determination method using FTIR. Int J Appl Pharm. 2016 May 3;8(3):43-7.

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. (R1): validation of analytical procedures: text and methodology. International Conference on Harmonization. Vol. Q2. India; 2005.