Head-to-Head Comparison of UHPLC-MS/MS and Alinity C for Plasma Analysis of Risperidone and Paliperidone
<b>Background and objectives:</b> Risperidone, a second-generation antipsychotic widely used in the treatment of schizophrenia, requires therapeutic drug monitoring due to its high interindividual variability. UHPLC-MS/MS is considered the gold standard for pharmacokinetic studies owing...
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| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2024-10-01
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| Series: | Pharmaceuticals |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1424-8247/17/11/1446 |
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| Summary: | <b>Background and objectives:</b> Risperidone, a second-generation antipsychotic widely used in the treatment of schizophrenia, requires therapeutic drug monitoring due to its high interindividual variability. UHPLC-MS/MS is considered the gold standard for pharmacokinetic studies owing to its superior sensitivity and specificity, although it involves time-consuming manual sample preparation. In contrast, the Alinity C system, fully automated, simplifies sample processing, but only measures the active moiety (risperidone plus paliperidone). The aim of this study is to compare the performance of UHPLC-MS/MS and the Alinity C system for the determination of risperidone and paliperidone concentrations in plasma. <b>Methods:</b> A total of 115 plasma samples of 115 patients, 92 and 23 under risperidone and paliperidone long-acting treatment, respectively, were analyzed using both methods. <b>Results:</b> A strong correlation for the active moiety (risperidone plus 9-OH-Risperidone) (rs = 0.95) was observed. However, Bland–Altman analysis revealed a mean bias of 0.996 ng/mL, indicating that the Alinity C system slightly overestimates concentrations compared to UHPLC-MS/MS. While there was substantial agreement between methods (κ = 0.72), discrepancies were observed in 16.3% of cases, which could impact clinical decision-making. When analyzing paliperidone separately, the agreement was lower (κ = 0.63), with greater variability observed. <b>Conclusions:</b> These findings suggest that, while the Alinity C system is suitable for routine therapeutic monitoring, UHPLC-MS/MS remains the preferred method in clinical scenarios requiring higher precision, particularly for patients with concentrations near therapeutic thresholds. |
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| ISSN: | 1424-8247 |