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Validation of liquid-liquid extraction followed by flow-injection negative ion electrospray mass spectrometry assay to Topiramate in human plasma.

This paper describes the development and validation of a method for the quantitative analysis of Topiramate (2,3:4,5-bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate), a new antiepileptic drug, in human plasma using liquid-liquid extraction followed by flow-injection negative ion electrospray mass spectrometry. Using Prednisone (1,4-pregnadiene-17-alpha,21-diol-3,11,20-trione [10 microg/mL]) as an internal standard, calibration curves for Topiramate were linear over a range of 1 to 30 microg/mL in human plasma and were highly reliable (r(2) = 0.9991). The lower limit of quantitation of the assay was 2 microg/mL in human plasma. Precision (%CV <15%) and accuracy (<20%) for both intra- and inter-day validations were satisfactory. The method has been used in clinical pharmacology research.