Structural Elucidation of Alkali Degradation Impurities of Favipiravir from the Oral Suspension: UPLC-TQ-ESI-MS/MS and NMR
A novel stability-indicating, reversed-phase, high-performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of favipiravir in an oral suspension. The effective separation of favipiravir and its degradation products was achieved on a Zorbax Eclipse Plus C18...
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| Format: | Article |
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MDPI AG
2022-08-01
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| Series: | Molecules |
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| Online Access: | https://www.mdpi.com/1420-3049/27/17/5606 |
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| author | Ravi Patel Abhishek Dube Ravisinh Solanki Dignesh Khunt Shalin Parikh Vijayabhaskarreddy Junnuthula Sathish Dyawanapelly |
| author_facet | Ravi Patel Abhishek Dube Ravisinh Solanki Dignesh Khunt Shalin Parikh Vijayabhaskarreddy Junnuthula Sathish Dyawanapelly |
| author_sort | Ravi Patel |
| collection | DOAJ |
| description | A novel stability-indicating, reversed-phase, high-performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of favipiravir in an oral suspension. The effective separation of favipiravir and its degradation products was achieved on a Zorbax Eclipse Plus C18 column (5 μm particle size, 150 mm length × 4.6 mm diameter). The mobile phase was prepared by mixing 5 mM of phosphate buffer (pH 3.5) and methanol in a 75:25 <i>v/v</i> ratio delivered at a 1.0 mL/min flow rate. The eluents were monitored using a photodiode array detector at a wavelength of 322 nm. The stability-indicating nature of this method was evaluated by performing force degradation studies under various stress conditions, such as acidic, alkali, oxidative, thermal, and photolytic degradation. Significant degradation was observed during the alkali stress degradation condition. The degradation products generated during various stress conditions were well separated from the favipiravir peak. In addition, the major degradation product formed under alkali stress conditions was identified using UPLC-ESI-TQ-MS/MS and NMR. Method validation was performed according to the ICH Q2 (R1) guideline requirements. The developed method is simple, accurate, robust, and reliable for routine quality control analysis of favipiravir oral suspensions. |
| first_indexed | 2024-03-10T01:29:58Z |
| format | Article |
| id | doaj.art-ac3f38800b0f40bc9530715bc6cded12 |
| institution | Directory Open Access Journal |
| issn | 1420-3049 |
| language | English |
| last_indexed | 2024-03-10T01:29:58Z |
| publishDate | 2022-08-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Molecules |
| spelling | doaj.art-ac3f38800b0f40bc9530715bc6cded122023-11-23T13:45:01ZengMDPI AGMolecules1420-30492022-08-012717560610.3390/molecules27175606Structural Elucidation of Alkali Degradation Impurities of Favipiravir from the Oral Suspension: UPLC-TQ-ESI-MS/MS and NMRRavi Patel0Abhishek Dube1Ravisinh Solanki2Dignesh Khunt3Shalin Parikh4Vijayabhaskarreddy Junnuthula5Sathish Dyawanapelly6Graduate School of Pharmacy, Gujarat Technological University, Gandhinagar 382028, Gujarat, IndiaGraduate School of Pharmacy, Gujarat Technological University, Gandhinagar 382028, Gujarat, IndiaGraduate School of Pharmacy, Gujarat Technological University, Gandhinagar 382028, Gujarat, IndiaGraduate School of Pharmacy, Gujarat Technological University, Gandhinagar 382028, Gujarat, IndiaSenores Pharmaceuticals Pvt. Ltd., Ahmedabad 380058, Gujarat, IndiaDrug Research Program, Faculty of Pharmacy, University of Helsinki, Viikinkaari 5 E, 00790 Helsinki, FinlandDepartment of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Mumbai 400019, Maharashtra, IndiaA novel stability-indicating, reversed-phase, high-performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of favipiravir in an oral suspension. The effective separation of favipiravir and its degradation products was achieved on a Zorbax Eclipse Plus C18 column (5 μm particle size, 150 mm length × 4.6 mm diameter). The mobile phase was prepared by mixing 5 mM of phosphate buffer (pH 3.5) and methanol in a 75:25 <i>v/v</i> ratio delivered at a 1.0 mL/min flow rate. The eluents were monitored using a photodiode array detector at a wavelength of 322 nm. The stability-indicating nature of this method was evaluated by performing force degradation studies under various stress conditions, such as acidic, alkali, oxidative, thermal, and photolytic degradation. Significant degradation was observed during the alkali stress degradation condition. The degradation products generated during various stress conditions were well separated from the favipiravir peak. In addition, the major degradation product formed under alkali stress conditions was identified using UPLC-ESI-TQ-MS/MS and NMR. Method validation was performed according to the ICH Q2 (R1) guideline requirements. The developed method is simple, accurate, robust, and reliable for routine quality control analysis of favipiravir oral suspensions.https://www.mdpi.com/1420-3049/27/17/5606RP-HPLCstability indicatingCOVID-19UPLC-MS/MScharacterizationfavipiravir |
| spellingShingle | Ravi Patel Abhishek Dube Ravisinh Solanki Dignesh Khunt Shalin Parikh Vijayabhaskarreddy Junnuthula Sathish Dyawanapelly Structural Elucidation of Alkali Degradation Impurities of Favipiravir from the Oral Suspension: UPLC-TQ-ESI-MS/MS and NMR Molecules RP-HPLC stability indicating COVID-19 UPLC-MS/MS characterization favipiravir |
| title | Structural Elucidation of Alkali Degradation Impurities of Favipiravir from the Oral Suspension: UPLC-TQ-ESI-MS/MS and NMR |
| title_full | Structural Elucidation of Alkali Degradation Impurities of Favipiravir from the Oral Suspension: UPLC-TQ-ESI-MS/MS and NMR |
| title_fullStr | Structural Elucidation of Alkali Degradation Impurities of Favipiravir from the Oral Suspension: UPLC-TQ-ESI-MS/MS and NMR |
| title_full_unstemmed | Structural Elucidation of Alkali Degradation Impurities of Favipiravir from the Oral Suspension: UPLC-TQ-ESI-MS/MS and NMR |
| title_short | Structural Elucidation of Alkali Degradation Impurities of Favipiravir from the Oral Suspension: UPLC-TQ-ESI-MS/MS and NMR |
| title_sort | structural elucidation of alkali degradation impurities of favipiravir from the oral suspension uplc tq esi ms ms and nmr |
| topic | RP-HPLC stability indicating COVID-19 UPLC-MS/MS characterization favipiravir |
| url | https://www.mdpi.com/1420-3049/27/17/5606 |
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