ESTIMATION OF TOPIRAMATE IN HUMAN PLASMA USING LC-MS/MS METHOD
Abstract
Objective: The objective 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 Topiramate in human plasma.
Method: The analytical method consists of solid phase extraction of plasma sample followed by the determination of Topiramate by a LC–MS/MS. The analyte was separated on Advance Hypurity C18 (50 x 4.6 mm, 5µ) column with an isocratic mobile phase of Acetonitrile and 2mM ammonium acetate buffer in the volume ratio of 80:20 v/v at a flow rate of 0.8 mL/min.     Results: Protonated ions formed by a turbo ion spray in a negative mode were used to detect analyte and internal standard (IS). The MS/MS detection was made by monitoring the fragmentation of m/z 338.00→77.50 for Topiramate and m/z 350.40→90.10 for internal standard on a mass spectrometer. The method was validated over the concentration range of 20.721 ng/mL to 605.656 ng/mL for Topiramate in human plasma with correlation coefficient greater than 0.99.
Conclusion: The developed method was successfully applied for analyzing Topiramate in plasma samples for a bioequivalence study with healthy volunteers.
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Key words: Topiramate; Validation; Analysis; Bioavailability; LC-MS/MS.
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References
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