A validated stability indicating RP-UFLC method for the estimation of Trifluridine – Anti viral drug

• Published in: Research journal of pharmacy and technology Vol. 15; no. 6; pp. 2681 - 2687
• Main Authors: Kumar Bandaru, Sai Pavan, Mathrusri Annapurna, Mukthinuthalapati
• Format: Journal Article
• Language: English
• Published: Raipur A&V Publications 28.06.2022
• Subjects: Acids; Antiviral drugs; Chromatography; Ions; Microemulsions; Sensors; Viral infections; India
• ISSN: 0974-3618; 0974-360X; 0974-306X
• DOI: 10.52711/0974-360X.2022.00448

Trifluridine, also known as trifluoro thymidine is an anti-viral drug used for the treatment of viral infections of eyes. A new validated RP-UFLC method has been developed for the determination of Trifluridine using Shimadzu Model UFLC system SPD-M20A 230V with PDA detector and LC- 20AD pumps and C18 Shim-pack GWS HPLC packed column (250 mm × 4.60 mm, 5 μm) in in ophthalmic preparations. Mobile phase consisting of acetonitrile: 10 mM potasium dihydrogen phosphate buffer adjusted pH to 3.5 with dilute tri fluro acetic acid (70:30 v/v) (Isocratic mode) with 1.0 mL/min flow rate (Detection wavelength 272 nm) are the chromatographic conditions for the present study. Trifluridine obeys Beer-Lambert’s law over the concentration range 0.1-120 µg/mL with linear regression equation y = 46195x – 1876.5 (R² = 0.9998) and the method was validated as per ICH guidelines. The LOQ and LOD values were found to be 0.08934 µg/mL and 0.0257 µg/mL respectively. Trifluridine was exposed to different stress conditions such as alkaline hydrolysis, acidic hydrolysis, oxidation and thermal degradation and the assay was carried out. The proposed method is simple, precise, accurate, robust and used for the routine analysis of marketed formulations.