title: LC/MS/MS quantitation of an anti-cancer drug in human plasma using a solid-phase extraction workstation: application to population pharmacokinetics.
abstract: A liquid chromatographic/mass spectrometric (LC/MS/MS) method to quantitate an anti-cancer drug in human plasma was validated. The method has proven suitable for routine quantitation of the experimental anti-cancer compound at concentrations from 1 to 400 ng/ml. Retention times of the compound and internal standard (compounds I and II, respectively) were 1.8 and 2.1 min, respectively. No interfering endogenous peaks were observed throughout the validation process. Precision estimates for this approach were typically less than 5% relative standard deviation (RSD) across the calibration range. Other validation parameters studied included specificity, system reproducibility, limit of quantitation, accuracy, linear range, and stability of the compound and internal standard in plasma and injection solvent. This method was used to quantify drug for population pharmacokinetic studies.
authors.affiliation: Department of Pharmacokinetics, Bioanalytical Core Group, Dynamics and Metabolism, Pfizer Global Research and Development, 2800 Plymouth Road, Ann Arbor, MI 48105, USA. lara.penn@pfizer.com
authors.forename: L D
authors.initials: LD
authors.lastname: Penn
authors.forename: L H
authors.initials: LH
authors.lastname: Cohen
authors.forename: S C
authors.initials: SC
authors.lastname: Olson
authors.forename: D T
authors.initials: DT
authors.lastname: Rossi
mesh_terms: D000970:Antineoplastic Agents / Q000097:blood* / Q000493:pharmacokinetics; D002853:Chromatography, Liquid; D004355:Drug Stability; D006801:Humans; D013058:Mass Spectrometry; D012680:Sensitivity and Specificity
chemical_list: D000970:Antineoplastic Agents