Development of an LC–MS/MS method for the simultaneous quantification of aripiprazole and dehydroaripiprazole in human plasma

Abstract

A selective, sensitive, and accurate liquid chromatography–tandem mass spectrometry (LC–MS/MS) method for the simultaneous determination of aripiprazole and its active metabolite dehydroaripiprazole in human plasma has been developed using papaverine as internal standard (IS). LC–MS/MS analysis was carried out on a Finnigan LC–TSQ Quantum mass spectrometer using positive ion electrospray ionization (ESI +) and selected reaction monitoring (SRM). The assays for aripiprazole and dehydroaripiprazole were linear over the ranges of 0.1 to 600 ng/ml and 0.01 to 60 ng/ml, respectively. The average recoveries in plasma samples both were better than 85%. The intra- and interrun precision and accuracy values were found to be within the assay variability criteria limits according to the US Food and Drug Administration guidelines. The developed method was proved to be suitable for use in a clinical pharmacokinetic study after a single oral administration of a 5-mg aripiprazole tablet in healthy Chinese volunteers.