title: A simple, rapid and specific method for measurement of topiramate in human plasma by LC-MS/MS employing automated solid-phase extraction techniques: Application for bioequivalence study.
abstract: A rapid liquid chromatography coupled with ESI tandem mass spectrometry (LC-MS/MS) method was developed and validated for the quantification 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 d-12 internal standard (IS) were chromatographed on a Betasil C18 column at a flow rate of 0.5 mL/min. The total run time was 1.80 min. An ESI interface with negative ion mode 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≥0.9992. 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 and fed pharmacokinetic studies.
authors.affiliation: Padmashri Vikhe Patil College, Pravaranagar, Loni Kurd, Dis-Ahmednagar, Maharashtra State, India.
authors.forename: Shashikant R
authors.initials: SR
authors.lastname: Kuchekar
authors.forename: Bhaskar H
authors.initials: BH
authors.lastname: Zaware
authors.forename: Mohan L
authors.initials: ML
authors.lastname: Kundlik