Article ID Journal Published Year Pages File Type
2507806 Journal of Pharmaceutical Analysis 2013 5 Pages PDF
Abstract

A stability-indicating RP-HPLC method was developed and validated for the determination of Rufinamide in tablet dosage forms using C 18 column (250 mm×4.6 mm, 5 μm) with mobile phase consisting of water–acetonitrile (40:60, v/v) with a flow rate of 0.8 mL/min (UV detection 215 nm). Linearity was observed over the concentration range 1.0–200 μg/mL (R2=0.9997) with regression equation y=113190 x+63053. Rufinamide was subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation. Rufinamide is more sensitive towards acidic degradation. The method was validated as per ICH guidelines.

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Health Sciences Pharmacology, Toxicology and Pharmaceutical Science Pharmaceutical Science
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