Experimental design approach for development of spectrofluorimetric method for determination of favipiravir; a potential therapeutic agent against COVID-19 virus: Application to spiked human plasma

Megahed, Safa M.; Habib, Ahmed; Hammad, Sherin F.; Kamal, Amira H.

doi:10.1016/j.saa.2020.119241

Cited by 93 publications

(75 citation statements)

References 13 publications

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“…The% degradation of the study was found to be 100.1%, which is allowed under ICH guidelines. Therefore, we hereby conclude that the developed method is accurate, accurate, sensitive, and reproducible for the quantitative estimation of Favipiravir bulk and its formulation [6,11,12,15,2,16].…”

Section: Degradation Studiesmentioning

confidence: 63%

“…5]. The label claim of the Favipiravir was 200 mg and we found it to be 204 mg in the tablet assay of Favipiravir using this developed method in Table 6 [6,2].…”

Section: Quantification Of Favipiravir In Formulationmentioning

confidence: 90%

“…Toyama Chemical Co. Ltd. discovered Favipiravir by examining a chemical library for antiviral activity against the influenza virus. Recognized as a substrate by RdRp and inhibits RNA polymerase activity [1,2]. As the catalytic domain of RdRp is conserved among various types of RNA viruses, this mechanism of action supports a broader spectrum of antiviral activities than Favipiravir.…”

Section: Introductionmentioning

confidence: 91%

“…In optimized chromatographic conditions, each standard solution was chromatograph for 10 min three times. Least squares linear regression analysis of theaverage peak area versus concentration data were used to evaluate the linearity of the method.The linearity for Favipiravir was assessed by analysis of standard solution in a range of 50-250 μg/ml [15,2,16].…”

Section: Linearitymentioning

confidence: 99%

“…All degradation graphs were represented between Fig. 9 to 14 [6,11,12,13,14,15,2,16,17,18,19,20,3,4].…”

Section: Degradation Studiesmentioning

confidence: 99%

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Analytical Method Development and Validation and Forced Degradation Stability-Indicating Studies of Favipiravir by RP-HPLC and UV in Bulk and Pharmaceutical Dosage Form

Ali¹,

Mobina²,

Mehfuza³

et al. 2021

JPRI

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Aims: To develop and validate a new, simple, rapid, precise, and accurate An Eco-friendly RP-HPLC and UV-Method Development and Validation for an estimation of Favipiravir in Bulk and pharmaceutical dosage form followed by Forced Degradation Studies. Study Design: This was employed for UV-visible (200-400 nm and 400-800 nm respectively) and RP-HPLC method development using C 18 inertsil column and optimization of variables for Favipiravir estimation in bulk and formulations. Place and Duration of the Study: The present work was carried out at Ali-allana College of Pharmacy, Akkalkuwa between the duration of November-2020 to February-2021. Methodology: UV-Spectroscopic method was developed for the estimation of Favipiravir in the bulk and pharmaceutical dosage form. The solvent selected for the Favipiravir UV analysis was water, the solution in a range of 2-10µg/ml was scanned in the UV region from 200-400 nm and the λmax value was determined. The RP-HPLC method was developed on inertsil ODS-3V C18 150 mm x 4.6mm x 5μ column using buffer pH 3.5: acetonitrile [90:10] as mobile phase at flow rate 1.0 ml/min and PDA detection at 358 nm. Results: The maximum absorbance was observed at 358 nm. The wavelength 358 nm was selected for further analysis of Favipiravir. The calibration curve was determined using drug concentrations ranging from 2-10 µg/ml. The % recovery for accuracy was 100.50-100.76%. The method was to be precise with a % RSD value 0.51-1.37 and 0.77-1.78 for intraday and Interday respectively. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 0.0723 &0.219 µg/ml respectively by UV method. The RP-HPLC method was shown to be linear in the 50-250 μg/ml concentration range. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 2.186 & 6.626 μg/ml respectively. The method was to be precise with a % RSD value 0.25-1.53 and 0.86-1.68 for intraday and inter-day respectively. Conclusion: Here we conclude that the developed UV and RP-HPLC methods are precise, accurate, sensitive, and reproducible for the quantitative estimation of Favipiravir bulk and its formulation. The developed method can be used by the pharmaceutical industries for the routine analysis of Favipiravir, in particular by UV and RP-HPLC. The main features of the proposed method are economic and eco-friendly with less retention time around 5.0 min.

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Section: Degradation Studiesmentioning

confidence: 63%

“…5]. The label claim of the Favipiravir was 200 mg and we found it to be 204 mg in the tablet assay of Favipiravir using this developed method in Table 6 [6,2].…”

Section: Quantification Of Favipiravir In Formulationmentioning

confidence: 90%

Section: Introductionmentioning

confidence: 91%

Section: Linearitymentioning

confidence: 99%

“…All degradation graphs were represented between Fig. 9 to 14 [6,11,12,13,14,15,2,16,17,18,19,20,3,4].…”

Section: Degradation Studiesmentioning

confidence: 99%

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Analytical Method Development and Validation and Forced Degradation Stability-Indicating Studies of Favipiravir by RP-HPLC and UV in Bulk and Pharmaceutical Dosage Form

Ali¹,

Mobina²,

Mehfuza³

et al. 2021

JPRI

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Quantitative analysis of favipiravir and hydroxychloroquine as FDA‐approved drugs for treatment of COVID‐19 using synchronous spectrofluorimetry: application to pharmaceutical formulations and biological fluids

et al. 2022

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Coronavirus disease 2019 (COVID‐19) is a contagious viral infection caused by coronavirus 2 (SARS‐CoV‐2) that causes severe acute respiratory syndrome. It has ravaged several countries and burdened many healthcare systems. As the process of authorizing a novel treatment for human use is extensive and involves multiple phases to obtain safety information and identify potential concerns. Therefore, the fastest and easiest choice was to use United States Food and Drug Administration (US FDA)‐approved drugs such as favipiravir and hydroxychloroquine. For the simultaneous estimation of both medications, a simple synchronous spectrofluorimetric approach was established in which both drugs were measured at 372 and 323 nm, respectively in the presence of each other without interference at Δλ 60 nm. The effect of various experimental conditions on synchronous fluorescence intensities were thoroughly investigated and optimized. The maximum synchronous fluorescence intensities were obtained at pH 5.4 using acetate buffer (0.2 M, 0.5 ml) and ethanol as a diluent. Excellent linearity ranges were obtained using 1.0–18.0 ng/ml and 10.0–120.0 ng/ml for favipiravir and hydroxychloroquine, respectively. The approach exhibited high sensitivity with detection limits down to 0.25 ng/ml and 1.52 ng/ml and quantitation limits down to 0.77 ng/ml and 4.62 ng/ml, respectively. Spiking human plasma samples with the studied drugs yielded high % recoveries, allowing a significant bioanalytical application. Moreover, the method was validated according to International Conference on Harmonization guidelines and further applied to commercial pharmaceutical preparations with good results.

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An ultrasensitive green synchronous factorized spectrofluorimetric approach for the simultaneous determination of Favipiravir and Molnupiravir: Application to pharmaceutical, environmental, and biological matrices

ElSherbiny,

Eid,

Kelani

et al. 2024

Luminescence

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During the pandemic, Favipiravir (FVP) and Molnupiravir (MPV) have been widely used for COVID‐19 treatment, leading to their presence in the environment. A green synchronous spectrofluorimetric method was developed to simultaneously detect them in environmental water, human plasma, and binary mixtures. Maximum fluorescence intensity was achieved at pH 8, with MPV exhibiting two peaks at 300 and 430 nm, and FVP showing one peak at 430 nm. A fluorescence subtraction method effectively removed interference, enabling direct determination of MPV at 300 nm and FVP at 430 nm. The method showed linearity within 2–13 ng/mL for FVP and 50–600 ng/mL for MPV, with recoveries of 100.35% and 100.12%, respectively. Limits of detection and quantification were 0.19 and 0.57 ng/mL for FVP and 10.52 and 31.88 ng/mL for MPV. Validation according to ICH and FDA guidelines yielded acceptable results. The method demonstrated good recoveries of FVP and MPV in pharmaceuticals, tap water and Nile water (99.62% ± 0.96% and 99.69% ± 0.64%) as per ICH guidelines and spiked human plasma (94.87% ± 2.111% and 94.79% ± 1.605%) following FDA guidelines, respectively. Its environmental friendliness was assessed using Green Analytical Procedure Index (GAPI) and the Analytical Greenness Metric (AGREE) tools.

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Experimental design approach for development of spectrofluorimetric method for determination of favipiravir; a potential therapeutic agent against COVID-19 virus: Application to spiked human plasma

Abstract: Graphical abstract

Cited by 93 publications

References 13 publications

Analytical Method Development and Validation and Forced Degradation Stability-Indicating Studies of Favipiravir by RP-HPLC and UV in Bulk and Pharmaceutical Dosage Form

Analytical Method Development and Validation and Forced Degradation Stability-Indicating Studies of Favipiravir by RP-HPLC and UV in Bulk and Pharmaceutical Dosage Form

Quantitative analysis of favipiravir and hydroxychloroquine as FDA‐approved drugs for treatment of COVID‐19 using synchronous spectrofluorimetry: application to pharmaceutical formulations and biological fluids

An ultrasensitive green synchronous factorized spectrofluorimetric approach for the simultaneous determination of Favipiravir and Molnupiravir: Application to pharmaceutical, environmental, and biological matrices

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