Validation of a dried blood spot method for therapeutic drug monitoring of citalopram, mirtazapine and risperidone and its active metabolite 9-hydroxyrisperidone using HPLC –MS

Publication date: 5 June 2017 Source:Journal of Pharmaceutical and Biomedical Analysis, Volume 140 Author(s): Johanna Weber, Stefanie Oberfeld, Andrea Bonse, Klaus Telger, Rainer Lingg, Georg Hempel Citalopram, mirtazapine and risperidone are frequently prescribed for psychiatric illnesses such as depression and psychosis or for aggressive behavior in elderly patients with dementia. The plasma concentrations vary greatly between patients, especially in elderly patients. Thus, therapeutic drug monitoring (TDM) increases the safety of antipsychotic treatment and a more rapid response to treatment may be achieved. To facilitate TDM, the objectives of this study were to develop and validate a reliable dried blood spot method to simultaneously quantify citalopram, mirtazapine and risperidone including its active metabolite 9-hydroxyrisperidone. The blood punches were extracted by methanol using an ultrasonic bath, purified by liquid–liquid extraction and analyzed by liquid chromatography/mass spectrometry (LC–MS). All acceptance criteria of the EMA and FDA guidelines for method validation were fulfilled. Linearity was shown over the range of 2.5–300μg/L for all substances. The analytes were stable for at least one month at all investigated storage conditions, including storing at room temperature exposed to light. Retrieving capillary blood by finger-pricking the assay was successfully applied in elderly patients. Venous serum samples were drawn simultaneously to co...
Source: Journal of Pharmaceutical and Biomedical Analysis - Category: Drugs & Pharmacology Source Type: research