A novel GC–MS assay method for the therapeutic drug monitoring of the atomoxetine

Abstract

© 2021 Elsevier B.V.Atomoxetine is used commonly treatment of attention deficit hyperactivity disorder in children, adolescents, and adults. A validated GC–MS assay for the quantitation of atomoxetine in human plasma is presented in the study. The assay method is the first GC–MS-based method reported for the analysis of atomoxetine in plasma for therapeutic drug monitoring. The method has rapid analysis time and simple sample preparation. Atomoxetine and internal standard (IS) pseudoephedrine were extracted from plasma using a liquid-liquid extraction method. The assay method was validated according to the European Medicines Agency (EMA) Guideline on bioanalytical method validation. The lower limit of quantitation of the developed method was 200 ng/mL for atomoxetine. The calibration curve of atomoxetine was between 200 and 2000 ng/mL with showing correlation coefficients >0.99. Also, the method was applied to real patient's plasma.