Development of a Validated Stability-Indicating HPTLC Method for Rufinamide in Bulk and Its Pharmaceutical Dosage Form

Abstract

A sensitive, selective, precise and stability indicating a high-performance thin layer chromatographic method for the analysis of rufinamide (Rf) in bulk drug and its formulations was developed and validated. The method employed thin layer chromatography aluminum plates precoated with silica gel 60 F254 as the stationary phase. The solvent system consisted of chloroform : methanol : glacial acetic acid (9 : 1 : 0.1 v/v/v). This system was found to give compact spots for Rf (Rf value of 0.68 ± 0.02). Rf was subjected to acid and alkali hydrolysis, oxidation, photodegradation and dry heat treatment. Also, the degraded products were well separated from the pure drug. Densitometric analysis of Rf was carried out in the absorbance mode at 210 nm, which is wavelength maxima for the degradant. The linear regression data for the calibration plots showed a good linear relationship with an r(2) of 0.9989 in the concentration range of 1,000-3,500 ng. The method was validated for precision, accuracy, ruggedness and recovery. The limits of detection and quantitation were 196.59 and 595.74 ng spot(-1), respectively. The drug undergoes degradation under acidic and basic conditions. All the peaks of degraded products were resolved from the standard drug with significantly different Rf values.