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

Abstract

This paper describes the development and validation of a method for the quantitative analysis of Topiramate (2,3:4,5-bis-O-(1-methylethylidene)-β-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-α,21-diol-3,11,20-trione [10 μg/mL]) as an internal standard, calibration curves for Topiramate were linear over a range of 1 to 30 μg/mL in human plasma and were highly reliable (r2 = 0.9991). The lower limit of quantitation of the assay was 2 μg/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. Copyright © 2001 John Wiley & Sons, Ltd.