دورية أكاديمية
QbD-Based Stability-Indicating RP-HPLC Method Development and Validation for the Estimation of Favipiravir-An Eco-Friendly Approach.
| العنوان: | QbD-Based Stability-Indicating RP-HPLC Method Development and Validation for the Estimation of Favipiravir-An Eco-Friendly Approach. |
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| المؤلفون: | Chandana M S; CMR College of Pharmacy, Department of Pharmaceutical Analysis, Kandlakoya (V), Medchal Road, Hyderabad, Telangana, 501401, India., K S; Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Department of Pharmaceutical Chemistry, Sri Ramachandra Faculty of Pharmacy, Porur, Chennai, Tamil Nadu, 600116, India., A A; Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Department of Pharmaceutical Chemistry, Sri Ramachandra Faculty of Pharmacy, Porur, Chennai, Tamil Nadu, 600116, India., Narendra P; CMR College of Pharmacy, Department of Pharmaceutics, Kandlakoya (V), Medchal Road, Hyderabad, Telangana, 501401, India., K S; Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Department of Pharmaceutical Chemistry, Sri Ramachandra Faculty of Pharmacy, Porur, Chennai, Tamil Nadu, 600116, India. |
| المصدر: | Journal of AOAC International [J AOAC Int] 2024 May 02; Vol. 107 (3), pp. 377-386. |
| نوع المنشور: | Journal Article; Validation Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Oxford University Press Country of Publication: England NLM ID: 9215446 Publication Model: Print Cited Medium: Internet ISSN: 1944-7922 (Electronic) Linking ISSN: 10603271 NLM ISO Abbreviation: J AOAC Int Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2020- : Oxford : Oxford University Press Original Publication: Arlington, VA : AOAC International, c1992- |
| مواضيع طبية MeSH: | Pyrazines*/analysis , Pyrazines*/chemistry , Amides*/analysis , Amides*/chemistry , Drug Stability*, Chromatography, High Pressure Liquid/methods ; Antiviral Agents/analysis ; Antiviral Agents/chemistry ; Chromatography, Reverse-Phase/methods ; Limit of Detection |
| مستخلص: | Background: Analytical quality by design (AQbD) affords a systematic scaffolding to triumph a continuously validated, robust assay as well as life cycle management. The resuscitative repurposed drug favipiravir, an oral drug approved for reemerging pandemic influenza in Japan in 2014, is used for the treatment of life-threatening pathogens such as Ebola, Lassa virus, and currently COVID-19. Favipiravir is gaining a great deal of medical importance due to its pharmaceutical applications. Objective: To develop and validate a risk-based stability-indicating RP-HPLC method employing an AQbD approach using Central Composite Design (Design Expert Software 13.0) for the estimation of favipiravir. Method: The Quality Target Product Profile optimized were flow rate and mobile phase composition, thus assessing the critical analytical attributes (retention time, tailing factor, and number of theoretical plates) as the constraints of method robustness. The proposed technique was optimized with a C18 (150 × 4.6 mm, 5 µm) column and 0.1% orthophosphoric acid buffer-acetonitrile (50:50, v/v) as the mobile phase at a flow rate of 1 mL/min using diode-array detector (230 nm) eluted favipiravir at 2.3 min. Results: The optimized method validated as per ICH guideline Q2 (R1) was found to be eco-friendly, simple, precise (RSD 0.0051-1.2%), accurate (99.86-100.22%), linear (25-150 µg/mL), rugged (RSD 0.70%), and robust (RSD 0.6-1.6%) with a limit of detection and limit of quantitation of 1.140 µg/mL and 4.424 µg/mL, respectively. Conclusion: Forced degradation studies (acidic, alkaline, thermal, photolytic, and oxidative conditions) revealed the suitability of the AQbD method for the analysis of favipiravir in tablet formulation.The developed and validated AQbD method is less time consuming and can be used in the industry for routine quality control/analysis of bulk drug and marketed Favipiravir products. Highlights: A robust Design of Experiment enhanced stability-indicating analytical method was developed and validated for the estimation of favipiravir. Furthermore, the contemporary method would aid in extending the analysis of favipiravir in other formulations. (© The Author(s) 2024. Published by Oxford University Press on behalf of AOAC INTERNATIONAL. All rights reserved. For permissions, please email: journals.permissions@oup.com.) |
| المشرفين على المادة: | EW5GL2X7E0 (favipiravir) 0 (Pyrazines) 0 (Amides) 0 (Antiviral Agents) |
| تواريخ الأحداث: | Date Created: 20240206 Date Completed: 20240503 Latest Revision: 20240503 |
| رمز التحديث: | 20240503 |
| DOI: | 10.1093/jaoacint/qsae009 |
| PMID: | 38318977 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1944-7922 |
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| DOI: | 10.1093/jaoacint/qsae009 |