LC/MS/MS quantitation of an anti-cancer drug in human plasma using a solid-phase extraction workstation: application to population pharmacokinetics

A liquid chromatographic/mass spectrometric (LC/MS/MS) method to quantitate an anti-cancer drug in human plasma was validated. The method has proven s uitable for routine quantitation of the experimental anti-cancer compound a t concentrations from 1 to 400 ng/ml. Retention times of the compound and i nternal standard (compounds I and II, respectively) were 1.8 and 2.1 min, r espectively. No interfering endogenous peaks were observed throughout the v alidation process. Precision estimates for this approach were typically les s than 5% relative standard deviation (RSD) across the calibration range. O ther Validation parameters studied included specificity, system reproducibi lity, limit of quantitation, accuracy, linear range, and stability of the c ompound and internal standard in plasma and injection solvent. This method was used to quantify drug for population pharmacokinetic studies. (C) 2001 Elsevier Science B.V, All rights reserved.