New Analytical Methods for the Determination of New Anti-Viral Drug Favipiravir: A Potential Therapeutic Drug Against Covid-19 Virus, in Bulk and Dosage Forms

Abstract

Simple, accurate and robust analytical methods have been developed and validated for the determination of favipiravir (FVPR) by RP-HPLC and UV spectroscopy techniques as per the ICH guidelines. In the RP-HPLC method for FVPR determination, the mobile phase was ammonium acetate buffer pH 6.5 in pump Aand methanol in pump B. The C18 (Sunfire) 5 μm, 4.6 × 250 mm column was used as a stationary phase, and the detection wavelength was at 323 nm. Under these conditions, FVPR was eluted as a sharp peak at 2.65 min and the overall time taken for each injection was 10 min. In case of the UV spectroscopy method, standard FVPR solutions were prepared with pure ethanol and scanned from 250 to 400 nm and a flourishing spectrum was obtained at 323 nm. Hence, the wavelength of 323 nm was fixed for the whole process of validation in both techniques. The limit of detection (LOD) and limit of quantification (LOQ) in the RP-HPLC method were 1.0 and 3.5 μg/mL, respectively, and the linearity was established in the 10 to 50 μg/mL range. In the UV spectroscopy method, the LOD and LOQ values were found to be 3.5 and 12 μg/mL, respectively, and the linearity was established within 20 to 60 μg/mL range. The regression coefficient was found to exceed 0.999 in both methods. The proposed RP-HPLC and UV spectroscopy techniques are simple, accurate, rugged and robust.

Development and Validation of UV Spectroscopic method for the estimation of favipiravir in bulk and tablet dosage form

“…Literature survey revealed that there were few analytical methods have been reported for the determination of favipiravir in pure drug and pharmaceutical dosage forms by using UV 1-5 , HPLC 6-13 , RP-HPLC [14][15][16][17][18][19][20][21][22][23][24] and HPTLC 25 so far. The aim of present work is to develop and validate a novel, rapid, simple, precise and specific Area under curve UV Spectrophotometric method for estimation of favipiravir in bulk and tablet dosage form.…”

Stability Indicating and Green Solvent-assisted Chromatographic Analysis of an Antiviral Drug

“…However other anti-virals are estimated using different liquid chromatography techniques with green solvents such as gradient RP-HPLC-glibenclamide estimation using ethanol [7], Cefepime hydrochloride estimation using methanol [8], Rosuvastatin estimation using green solvent ethanol in RP-HPLC [9], Nevirapine and lamivudine using ethanol as solvent [10], Micellar chromatographic estimation of four antiviral drugs using Sodium Dodecyl Sulfate, Isopropanol, Triethylamine [11], Mixed micellar estimation of antiviral drugs using sodium lauryl sulfate [12] and other spectrophotometric-HPLC methods using green solvents [13] [14], famciclovir by RP-HPLC [15]. Certain green methods were reported using ethanol as a solvent for estimating nonantiviral drugs using HPLC such as deferasirox in human plasma [16], azosemide-micellar chromatography [17], impurities in deferasirox [18].…”

Spectrophotometric Determination of Favipiravir in Bulk and Pharmaceutical Formulation Using Bromothymol Blue Reagent

“…3,4 As per the literature survey, it was known that analytical methods were developed for the estimation of favipiravir formulations. The developed methods included spectroscopic methods such as UV spectroscopic methods, [5][6][7][8][9][10] Visible spectrophotometric methods, 11 Fourier Transform Infrared Spectroscopic (FTIR) method, 12 spectrofluorimetric method, 13,14 chromatographic methods such as RP-HPLC methods, [15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34] thin layer chromatography (TLC) 35 and hyphenated techniques such as UPLC-MS/MS methods, 36,37 LC-MS/MS methods [38][39][40][41][42] and electrical methods such as voltammetric methods. [43][44][45] But it was evident that only one method was developed for the estimation of favipiravir in pharmaceutical formulations using methyl orange and methyl red reagents in spectroscopy.…”