심영은 (대검찰청)

김진영 (대검찰청)

심영은 (대검찰청)

김정은 (대검찰청)

김지우 (대검찰청)

김진영 (대검찰청)

 Medication compliance monitoring is critical in managing probationers with mental health disorders. As the prescription of aripiprazole (APZ), a third-generation atypical antipsychotic, continues to increase, a rapid and robust analytical method for its verification in urine is essential. This study establishes a comprehensive measurement uncertainty budget for the quantification of APZ and its metabolite, dehydroaripiprazole (DAPZ), in urine using isotope dilution liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS). Following a simple dilute-and-shoot sample preparation, analytes were quantified using a weighted (1/x²) linear regression calibration with corresponding deuterated internal standards. In accordance with the 'Guide to the Expression of Uncertainty in Measurement' (GUM), a bottom-up approach was employed to systematically evaluate all significant uncertainty sources. The results revealed that method precision and calibration curve fitting were the dominant contributors to the combined uncertainty, whereas contributions from standard solution preparation and volumetric sample handling were relatively minor. The final relative expanded uncertainty (k=2, at 95% confidence level) for a real urine sample was determined to be 19.8% for APZ and 22.9% for DAPZ. This rigorous, GUM-compliant characterization confirms that the developed method is fit-for-purpose, providing reliable, quantitative results with a well-defined confidence interval essential for making informed decisions regarding probationer treatment adherence.