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<p>The monitoring of medication compliance is essential in managing probationers with mental disorders. With the increasing prescription of aripiprazole (APZ), which is a third-generation atypical antipsychotic, a rapid, reliable analytical method for verifying its presence in urine is critically necessary. This study established a comprehensive uncertainty budget for quantifying APZ and its metabolite, dehydroaripiprazole (DAPZ), in urine using isotope dilution–liquid chromatography-tandem mass spectrometry (ID<b>–</b>LC<b>–</b>MS/MS). After a straightforward dilute-and-shoot sample preparation, urinary APZ and DAPZ concentrations were quantified using weighted (1/<i>x</i><sup>2</sup>) linear regression calibration with deuterated internal standards. In accordance with the Guide to the Expression of Uncertainty in Measurement (GUM), a bottom-up approach was used to systematically evaluate the significant sources of uncertainty. Method precision and calibration curve were identified as the main contributors to overall uncertainty, whereas contributions from standard solution preparation and volumetric sample handling were relatively minor. The final relative expanded uncertainties (<i>k</i> = 2, 95% confidence level) for the quantification of APZ and DAPZ in real urine were 19.8% and 22.9%, respectively. This thorough, GUM-compliant characterization confirms that the developed method delivers reliable quantitative results with a clearly defined confidence interval, making it suitable for monitoring medication compliance and supporting informed decision-making regarding treatment adherence among probationers.</p>

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Evaluation of measurement uncertainties in quantifying urinary aripiprazole and dehydroaripiprazole via isotope dilution–LC–MS/MS

  • 期刊论文

  • 发表日期：

    2025年11月12日

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  • Yeong Eun Sim,
  • Jeong Eun Kim,
  • Ji Woo Kim,
  • Jin Young Kim

摘要

The monitoring of medication compliance is essential in managing probationers with mental disorders. With the increasing prescription of aripiprazole (APZ), which is a third-generation atypical antipsychotic, a rapid, reliable analytical method for verifying its presence in urine is critically necessary. This study established a comprehensive uncertainty budget for quantifying APZ and its metabolite, dehydroaripiprazole (DAPZ), in urine using isotope dilution–liquid chromatography-tandem mass spectrometry (ID–LC–MS/MS). After a straightforward dilute-and-shoot sample preparation, urinary APZ and DAPZ concentrations were quantified using weighted (1/x2) linear regression calibration with deuterated internal standards. In accordance with the Guide to the Expression of Uncertainty in Measurement (GUM), a bottom-up approach was used to systematically evaluate the significant sources of uncertainty. Method precision and calibration curve were identified as the main contributors to overall uncertainty, whereas contributions from standard solution preparation and volumetric sample handling were relatively minor. The final relative expanded uncertainties (k = 2, 95% confidence level) for the quantification of APZ and DAPZ in real urine were 19.8% and 22.9%, respectively. This thorough, GUM-compliant characterization confirms that the developed method delivers reliable quantitative results with a clearly defined confidence interval, making it suitable for monitoring medication compliance and supporting informed decision-making regarding treatment adherence among probationers.