A high-performance liquid chromatography-tandem mass spectrometric method for the determination of pharmacokinetics of ganaxolone in rat, monkey, dogand human plasma

A method for determining concentration levels of ganaxolone in rat, monkey, dog and human plasma was validated in the range of 5-1500 ng/ml using a 20 0-mul plasma sample volume. This validation report describes the linearity, specificity, sensitivity, reproducibility, accuracy, recovery and stabilit y of the analytical method. The inter-day C.V. ranged from 0.5 to 9.2%, int ra-day CN. from 0.7 to 8.8% and intra-day accuracy (mean absolute percentag e difference) ranged from 0.0 to 14.0% for rat, monkey, dog and human plasm a. The method was used for the routine analysis of ganaxolone in rat, monke y, dog and human plasma and summary of the pharmacokinetic data are present ed. (C) 2001 Elsevier Science B.V. All rights reserved.