Abstract

Topiramate is an anti-convulsant used to treat seizures and prevent migraines. The Purpose of this research was to develop and validate a simple, sensitive and specific liquid chromatography–tandem mass spectrometry (LC–MS/MS) method for quantification of Topiramatein its formulation. Acetonitrile and ammonium acetate were used as a mobile phase (85:15 v/v ratio) and isocratic elution mode was used for separation with Zorbax RP-C18Column (50 mm x 4.6 mm i.d., 5µ) as a stationary phase. The standard calibration curve ranges from 1 to 1000 ng/mL with a correlation coefficient of 0.9990 (r2). Detection and quantification limits were obtained at 0.5 ng/mL and 1.0 ng/mL. The runtime of chromatographic condition was found to be 2.0 min and the retention time at 1.23 min. The percentage recovery studies were found to be 90.3 - 99.3%. The developed method was validated as per international conference on harmonisation (ICH) guidelines.

Key words: Topiramate; liquid chromatography–tandem mass spectrometry; International Conference on Harmonisation.