Revista de Bioanálise e Biomedicina

Rapid and Specific Approach for Direct Measurement of Topiramate in Human Plasma by LC-MS/MS: Application for Bioequivalence Study

Abstract

S. R. Kuchekar, M. L. Kundlik and B. H. Zaware

A rapid liquid chromatography coupled with electrospray ionization tandem mass spectrometry (LC-MS/MS) method was developed and validated for the quanti fi cation of topiramate in heparinized human plasma. The plasma samples were prepared by solid phase extraction (SPE) method without drying and then reconstitution. Topiramate and the topiramate d12 (Internal Standard IS) were chromatographed on a Betasil C18 column at a fl ow rate of 0.5 ml/min. The total run time was 1.80 min. An electrospray ionization interface was selected for ionization of analyte and IS. The mass transition [M-H] ions used for detection were m/z 338.10 → 78.20 for topiramate, m/z 350.40 → 90.10 for IS. The method was linear in the concentration range of 10–4200 ng/ml with r ≥ 0.9982. Recovery of topiramate and IS ranged from 78.20 to 87.74%. The validated method has been successfully used to analyze human plasma samples for application in 100 mg fasted pharmacokinetic studies.