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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MDPI AG
2024-10-01
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| author | Francisco José Toja-Camba Gonzalo Hermelo-Vidal Carolina Feitosa-Medeiros María Vidal-Millares María José Durán-Maseda Anxo Fernández-Ferreiro Cristina Mondelo-García |
| author_facet | Francisco José Toja-Camba Gonzalo Hermelo-Vidal Carolina Feitosa-Medeiros María Vidal-Millares María José Durán-Maseda Anxo Fernández-Ferreiro Cristina Mondelo-García |
| author_sort | Francisco José Toja-Camba |
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| description | <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. |
| format | Article |
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| institution | OA Journals |
| issn | 1424-8247 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | MDPI AG |
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| series | Pharmaceuticals |
| spelling | doaj-art-0d342fa431d943c29539ba7cb0bf57322025-08-20T02:05:07ZengMDPI AGPharmaceuticals1424-82472024-10-011711144610.3390/ph17111446Head-to-Head Comparison of UHPLC-MS/MS and Alinity C for Plasma Analysis of Risperidone and PaliperidoneFrancisco José Toja-Camba0Gonzalo Hermelo-Vidal1Carolina Feitosa-Medeiros2María Vidal-Millares3María José Durán-Maseda4Anxo Fernández-Ferreiro5Cristina Mondelo-García6Pharmacy Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, SpainFarmaCHUSLab Group, Health Research Institute of Santiago de Compostela (IDIS), 15706 Santiago de Compostela, SpainFarmaCHUSLab Group, Health Research Institute of Santiago de Compostela (IDIS), 15706 Santiago de Compostela, SpainPsychiatry Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, SpainPsychiatry Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, SpainPharmacy Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, SpainPharmacy Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, Spain<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.https://www.mdpi.com/1424-8247/17/11/1446risperidonepaliperidoneUHPLC-MS/MSAlinity CpharmacokineticsTDM |
| spellingShingle | Francisco José Toja-Camba Gonzalo Hermelo-Vidal Carolina Feitosa-Medeiros María Vidal-Millares María José Durán-Maseda Anxo Fernández-Ferreiro Cristina Mondelo-García Head-to-Head Comparison of UHPLC-MS/MS and Alinity C for Plasma Analysis of Risperidone and Paliperidone Pharmaceuticals risperidone paliperidone UHPLC-MS/MS Alinity C pharmacokinetics TDM |
| title | Head-to-Head Comparison of UHPLC-MS/MS and Alinity C for Plasma Analysis of Risperidone and Paliperidone |
| title_full | Head-to-Head Comparison of UHPLC-MS/MS and Alinity C for Plasma Analysis of Risperidone and Paliperidone |
| title_fullStr | Head-to-Head Comparison of UHPLC-MS/MS and Alinity C for Plasma Analysis of Risperidone and Paliperidone |
| title_full_unstemmed | Head-to-Head Comparison of UHPLC-MS/MS and Alinity C for Plasma Analysis of Risperidone and Paliperidone |
| title_short | Head-to-Head Comparison of UHPLC-MS/MS and Alinity C for Plasma Analysis of Risperidone and Paliperidone |
| title_sort | head to head comparison of uhplc ms ms and alinity c for plasma analysis of risperidone and paliperidone |
| topic | risperidone paliperidone UHPLC-MS/MS Alinity C pharmacokinetics TDM |
| url | https://www.mdpi.com/1424-8247/17/11/1446 |
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