A Stability Indicating RP-HPLC Method for Estimation of Favipiravir in Tablets

ABSTRACT

Objectives: The focus of this research work was to develop an accurate and validated RP-HPLC technique for analysing Favipiravir (FAVI) drug and interpreting related degradants in drug and its formulation. Materials and Methods: The separation was performed on C18 column (Phenomenex Luna BDS Hypersil) with dimension of 4.6x150 mm and 5 µm of particle size at 40ºC in gradient mode. Two solvents mixture was used for analysis. Solvent A (water and 0.01% 10 mM ammonium acetate) and solvent B (acetonitrile) were used as a mobile phase at a rate of 0.5 mL/min and 323 nm wavelength used for detection. Results: The validated method was developed as per ICH parameters including LOD, accuracy, linearity, range, LOQ, precision and the observations were found to be satisfactory. The method was then processed for different degradation conditions. The FAVI was treated with various circumstances like hydrolysis, oxidation and photolytic stages for determination of degradation products. Retention time (tR) was observed at 3.337±0.01 min for FAVI. After stress testing three degradants were found. The first degradant D1 found at 4.170 min (tR), second D2 at 4.260 min (tR) and third D3 at 3.881 min (tR) were found in basic (1 N NaOH), acidic (1 N HCl) and oxidation (30% H2O2) conditions. All the degradants were interpreted by mass spectra. The molecular ion [M+1] m/z 156.8 was found in positive mode mass spectra. The various ion peaks were found at m/z 153.1, 130.0, 112.0 and 101.0. FAVI was observed to be degraded in all the conditions used. Conclusion: There FAVI drug, its formulations and degradants were identified and interpreted by quadrapole MS/MS system.

KEYWORDS

• Favipiravir
• RP-HPLC
• Stability indicating method
• Tablets
• Validation

Showing references and in-text citations exactly as published.

• DOI10.5530/ijper.20260817Copy

RELATED ARTICLES

Matched on section and article type within this issue of IJPER.

• Article · VOLUME 60, ISSUE 4Rapidly Disintegrating Ciprofloxacin Hydrochloride Tablets: A Novel Formulation Approach Using Superdisintegrant TechnologyKm. Anjali, Arvind Raghav · pp. 1394–1408Original ArticleSame type: Article
• Article · VOLUME 60, ISSUE 4Development and Characterization of Ranolazine-Loaded Solid Lipid Nanoparticles for Enhanced Angina TherapyPrasanna Shirgaonkar, Rutuja Chougale, Kiran Patil, Vibhuti Thakur, Firoj Tamboli, Somnath Bhinge, Shailendra Gurav · pp. 1409–1415Original ArticleSame type: Article
• Article · VOLUME 60, ISSUE 4Design and Development of Pulsatile Drug Delivery System of Bambuterol for Asthma TreatmentSanjay Jayaram, Manjunath Kopparam, Abdul Waris Khan · pp. 1416–1424Original ArticleSame type: Article
• Article · VOLUME 60, ISSUE 4Design and Optimization of Novel Anti-Tubercular Polyherbal Chewable Tablet Using Design ExpertJaya Martolia, Falguni Tandel, Hardik Soni · pp. 1425–1440Original ArticleSame type: Article