A Stability-Indicating HPLC Method for Favipiravir and its Related Substances

Didem Yazgı; Armağan Önal

Article Details

A Stability-Indicating HPLC Method for Favipiravir and its Related Substances

Authors:

Didem Yazgı | Armağan Önal

Publisher:

Istanbul University

Main Topics:

Pharmaceutical Analytical Chemistry

Journal:

İstanbul Journal of Pharmacy Vol.55 Issue 2, pp.267-273

Document Type:

Article

Publication Date:

9/2025

Document Language:

English

Document ID (Org No.):

2001353975

pISSN:

2587-2087

Keywords:

Abstract:

 Background and Aims: This study aimed to improve an HPLC method for the quantification of favipiravir FVP and its impurities and apply it to a marketed pharmaceutical product. Methods: Chromatographic separations were achieved on a C18 column. The mobile phase comprised 10 mM potassium dihydrogen phosphate buffer pH 4.0:acetonitrile 90:10 vv and acetonitrile in the gradient mode. The peaks were detected at 238 nm and the flow rate was set at 1.5 mLmin. The optimised method has been validated as per the International Conference on Harmonisation ICH guidelines Q2 R1. A sharp peak of FVP was obtained at 5.5 min with no interfering peaks. In addition, the degradation study was conducted under acidic, basic, oxidative, photolytic, and thermal stress conditions. Results: In the calibration curve experiments, the linearity was between 0.5  3 μgmL and r20.9985. Recovery ranging from 97.5 to 102.2 for the drug and impurities. The limit of detection LOD and limit of quantification LOQ concentrations of FVP and its impurities were 0.07 μgmL and 0.2 μgmL using s n:3, respectively. The precision studies were carried out and the relative standard deviation RSD values were found to be between 1.01 and 1.65 and 0.67-1.75 for intra-day precision and inter-day precision; respectively. No degradation peak appeared in the acidic hydrolysis, base hydrolysis, and photolysis stress studies. When the drug was subjected to thermal degradation, impurity B was observed. The degradation of the drug substances was obtained at 0.67 and 1.87 by thermal degradation and oxidation; respectively. Conclusion: The stability-indicating chromatographic methods for the determination of FVP and related components were developed and applied in tablets.

 Background and Aims: This study aimed to improve an HPLC method for the quantification of favipiravir FVP and its impurities and apply it to a marketed pharmaceutical product. Methods: Chromatographic separations were achieved on a C18 column. The mobile phase comprised 10 mM potassium dihydrogen phosphate buffer pH 4.0:acetonitrile 90:10 vv and acetonitrile in the gradient mode. The peaks were detected at 238 nm and the flow rate was set at 1.5 mLmin. The optimised method has been validated as per the International Conference on Harmonisation ICH guidelines Q2 R1. A sharp peak of FVP was obtained at 5.5 min with no interfering peaks. In addition, the degradation study was conducted under acidic, basic, oxidative, photolytic, and thermal stress conditions. Results: In the calibration curve experiments, the linearity was between 0.5  3 μgmL and r20.9985. Recovery ranging from 97.5 to 102.2 for the drug and impurities. The limit of detection LOD and limit of quantification LOQ concentrations of FVP and its impurities were 0.07 μgmL and 0.2 μgmL using s n:3, respectively. The precision studies were carried out and the relative standard deviation RSD values were found to be between 1.01 and 1.65 and 0.67-1.75 for intra-day precision and inter-day precision; respectively. No degradation peak appeared in the acidic hydrolysis, base hydrolysis, and photolysis stress studies. When the drug was subjected to thermal degradation, impurity B was observed. The degradation of the drug substances was obtained at 0.67 and 1.87 by thermal degradation and oxidation; respectively. Conclusion: The stability-indicating chromatographic methods for the determination of FVP and related components were developed and applied in tablets.

 Background and Aims: This study aimed to improve an HPLC method for the quantification of favipiravir FVP and its impurities and apply it to a marketed pharmaceutical product. Methods: Chromatographic separations were achieved on a C18 column. The mobile phase comprised 10 mM potassium dihydrogen phosphate buffer pH 4.0:acetonitrile 90:10 vv and acetonitrile in the gradient mode. The peaks were detected at 238 nm and the flow rate was set at 1.5 mLmin. The optimised method has been validated as per the International Conference on Harmonisation ICH guidelines Q2 R1. A sharp peak of FVP was obtained at 5.5 min with no interfering peaks. In addition, the degradation study was conducted under acidic, basic, oxidative, photolytic, and thermal stress conditions. Results: In the calibration curve experiments, the linearity was between 0.5  3 μgmL and r20.9985. Recovery ranging from 97.5 to 102.2 for the drug and impurities. The limit of detection LOD and limit of quantification LOQ concentrations of FVP and its impurities were 0.07 μgmL and 0.2 μgmL using s n:3, respectively. The precision studies were carried out and the relative standard deviation RSD values were found to be between 1.01 and 1.65 and 0.67-1.75 for intra-day precision and inter-day precision; respectively. No degradation peak appeared in the acidic hydrolysis, base hydrolysis, and photolysis stress studies. When the drug was subjected to thermal degradation, impurity B was observed. The degradation of the drug substances was obtained at 0.67 and 1.87 by thermal degradation and oxidation; respectively. Conclusion: The stability-indicating chromatographic methods for the determination of FVP and related components were developed and applied in tablets.

 Background and Aims: This study aimed to improve an HPLC method for the quantification of favipiravir FVP and its impurities and apply it to a marketed pharmaceutical product. Methods: Chromatographic separations were achieved on a C18 column. The mobile phase comprised 10 mM potassium dihydrogen phosphate buffer pH 4.0:acetonitrile 90:10 vv and acetonitrile in the gradient mode. The peaks were detected at 238 nm and the flow rate was set at 1.5 mLmin. The optimised method has been validated as per the International Conference on Harmonisation ICH guidelines Q2 R1. A sharp peak of FVP was obtained at 5.5 min with no interfering peaks. In addition, the degradation study was conducted under acidic, basic, oxidative, photolytic, and thermal stress conditions. Results: In the calibration curve experiments, the linearity was between 0.5  3 μgmL and r20.9985. Recovery ranging from 97.5 to 102.2 for the drug and impurities. The limit of detection LOD and limit of quantification LOQ concentrations of FVP and its impurities were 0.07 μgmL and 0.2 μgmL using s n:3, respectively. The precision studies were carried out and the relative standard deviation RSD values were found to be between 1.01 and 1.65 and 0.67-1.75 for intra-day precision and inter-day precision; respectively. No degradation peak appeared in the acidic hydrolysis, base hydrolysis, and photolysis stress studies. When the drug was subjected to thermal degradation, impurity B was observed. The degradation of the drug substances was obtained at 0.67 and 1.87 by thermal degradation and oxidation; respectively. Conclusion: The stability-indicating chromatographic methods for the determination of FVP and related components were developed and applied in tablets.

Article Details

A Stability-Indicating HPLC Method for Favipiravir and its Related Substances

Authors:

Didem Yazgı | Armağan Önal

Publisher:

Istanbul University

Main Topics:

Pharmaceutical Analytical Chemistry

Journal:

İstanbul Journal of Pharmacy Vol.55 Issue 2, pp.267-273

Document Type:

Article

Publication Date:

9/2025

Document Language:

English

Document ID (Org No.):

2001353975

pISSN:

2587-2087

Favipiravir

Pharmaceutical preparation

Stability-indicating

Validation

Issues

Article Details

A Stability-Indicating HPLC Method for Favipiravir and its Related Substances

Authors: Didem Yazgı | Armağan Önal

Publisher: Istanbul University

Main Topics: Pharmaceutical Analytical Chemistry

Journal: İstanbul Journal of Pharmacy Vol.55 Issue 2, pp.267-273

Document Type: Article

Publication Date: 9/2025

Document Language: English

Document ID (Org No.): 2001353975

pISSN: 2587-2087

Favipiravir

Pharmaceutical preparation

Stability-indicating

Validation

Issues

Authors:

Didem Yazgı | Armağan Önal

Publisher:

Istanbul University

Main Topics:

Pharmaceutical Analytical Chemistry

Journal:

İstanbul Journal of Pharmacy Vol.55 Issue 2, pp.267-273

Document Type:

Article

Publication Date:

9/2025

Document Language:

English

Document ID (Org No.):

2001353975

pISSN:

2587-2087