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Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry for Simultaneous Determination of Antipsychotic Drugs in Human Plasma and Its Application in Therapeutic Drug Monitoring
Drug Design, Development and Therapy ( IF 4.8 ) Pub Date : 2021-02-12 , DOI: 10.2147/dddt.s290963 Yingjie Qi 1 , Guangxuan Liu 1
Drug Design, Development and Therapy ( IF 4.8 ) Pub Date : 2021-02-12 , DOI: 10.2147/dddt.s290963 Yingjie Qi 1 , Guangxuan Liu 1
Affiliation
Purpose: We developed and validated an ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for simultaneous therapeutic drug monitoring (TDM) and clinical pharmacokinetic antipsychotic drugs: clozapine (CLP), chlorpromazine (CPZ), risperidone (RPD), paliperidone (PLD), quetiapine (QTP;), aripiprazole (APZ), dehydroaripiprazole (DAP), olanzapine (OZP), ziprasidone (ZRD), and amisulpride (ASP).
Methods: Analytes and internal standards (ISs) were separated using a Phenomenex phenyl-hexyl column (50.0 × 2.1 mm, 1.7 μm) with water containing 0.1% formic acid and 2 mM ammonium acetate, and methanol containing 0.1% formic acid and 2 mM ammonium acetate as the mobile phase. The antipsychotic drugs and ISs were extracted from 50 μL of plasma using acetonitrile.
Results: The calibration ranges were 25.0– 1500.0 ng/mL for CLP, CPZ, DAP, and QTP, 10.0– 600.0 ng/mL for CPZ and ZRD, 2.5– 150.0 ng/mL for RPD, 5.0– 300.0 ng/mL for PLD and OZP, and 20.0– 1200.0 ng/mL for ASP. Validation was carried out according to the guidelines for bioanalytical validation, including assessment of calibration curves, specificity, accuracy, precision, recovery, stability, dilution integrity, and matrix effect. All the results satisfied the requirements.
Conclusion: The results provided significant information to support future clinical TDM and rational drug use research. The proposed method also provided a simple, reliable, specific, and suitable technique for TDM and pharmacokinetic studies.
Keywords: UPLC, tandem mass spectrometry, antipsychotic drug, therapeutic drug monitoring, individualized therapy
中文翻译：
超高效液相色谱-串联质谱法同时测定人血浆中的抗精神病药物及其在治疗药物监测中的应用
目的：我们开发并验证了一种用于同时监测治疗药物（TDM）和临床药代动力学抗精神病药物的超高效液相色谱-串联质谱（UPLC-MS/MS）方法：氯氮平（CLP）、氯丙嗪（CPZ）、利培酮（ RPD)、帕利哌酮 (PLD)、喹硫平 (QTP)、阿立哌唑 (APZ)、脱氢阿立哌唑 (DAP)、奥氮平 (OZP)、齐拉西酮 (ZRD) 和氨磺必利 (ASP)。
方法：使用 Phenomenex 苯基-己基色谱柱 (50.0 × 2.1 mm, 1.7 μm) 分离分析物和内标物 (IS)，水含有 0.1% 甲酸和 2 mM 乙酸铵，甲醇含有 0.1% 甲酸和 2 mM醋酸铵作为流动相。使用乙腈从 50 μL 血浆中提取抗精神病药物和 IS。
结果： CLP、CPZ、DAP 和 QTP 的校准范围为 25.0–1500.0 ng/mL，CPZ 和 ZRD 的校准范围为 10.0–600.0 ng/mL，RPD 的校准范围为 2.5–150.0 ng/mL，PLD 的校准范围为 5.0–300.0 ng/mL和 OZP，ASP 为 20.0–1200.0 ng/mL。根据生物分析验证指南进行验证，包括评估校准曲线、特异性、准确度、精密度、回收率、稳定性、稀释完整性和基质效应。结果全部满足要求。
结论：该结果为支持未来临床 TDM 和合理用药研究提供了重要信息。所提出的方法还为 TDM 和药代动力学研究提供了一种简单、可靠、特异性和合适的技术。
关键词：UPLC、串联质谱、抗精神病药物、治疗药物监测、个体化治疗
更新日期：2021-04-20
Methods: Analytes and internal standards (ISs) were separated using a Phenomenex phenyl-hexyl column (50.0 × 2.1 mm, 1.7 μm) with water containing 0.1% formic acid and 2 mM ammonium acetate, and methanol containing 0.1% formic acid and 2 mM ammonium acetate as the mobile phase. The antipsychotic drugs and ISs were extracted from 50 μL of plasma using acetonitrile.
Results: The calibration ranges were 25.0– 1500.0 ng/mL for CLP, CPZ, DAP, and QTP, 10.0– 600.0 ng/mL for CPZ and ZRD, 2.5– 150.0 ng/mL for RPD, 5.0– 300.0 ng/mL for PLD and OZP, and 20.0– 1200.0 ng/mL for ASP. Validation was carried out according to the guidelines for bioanalytical validation, including assessment of calibration curves, specificity, accuracy, precision, recovery, stability, dilution integrity, and matrix effect. All the results satisfied the requirements.
Conclusion: The results provided significant information to support future clinical TDM and rational drug use research. The proposed method also provided a simple, reliable, specific, and suitable technique for TDM and pharmacokinetic studies.
Keywords: UPLC, tandem mass spectrometry, antipsychotic drug, therapeutic drug monitoring, individualized therapy
中文翻译：
超高效液相色谱-串联质谱法同时测定人血浆中的抗精神病药物及其在治疗药物监测中的应用
目的：我们开发并验证了一种用于同时监测治疗药物（TDM）和临床药代动力学抗精神病药物的超高效液相色谱-串联质谱（UPLC-MS/MS）方法：氯氮平（CLP）、氯丙嗪（CPZ）、利培酮（ RPD)、帕利哌酮 (PLD)、喹硫平 (QTP)、阿立哌唑 (APZ)、脱氢阿立哌唑 (DAP)、奥氮平 (OZP)、齐拉西酮 (ZRD) 和氨磺必利 (ASP)。
方法：使用 Phenomenex 苯基-己基色谱柱 (50.0 × 2.1 mm, 1.7 μm) 分离分析物和内标物 (IS)，水含有 0.1% 甲酸和 2 mM 乙酸铵，甲醇含有 0.1% 甲酸和 2 mM醋酸铵作为流动相。使用乙腈从 50 μL 血浆中提取抗精神病药物和 IS。
结果： CLP、CPZ、DAP 和 QTP 的校准范围为 25.0–1500.0 ng/mL，CPZ 和 ZRD 的校准范围为 10.0–600.0 ng/mL，RPD 的校准范围为 2.5–150.0 ng/mL，PLD 的校准范围为 5.0–300.0 ng/mL和 OZP，ASP 为 20.0–1200.0 ng/mL。根据生物分析验证指南进行验证，包括评估校准曲线、特异性、准确度、精密度、回收率、稳定性、稀释完整性和基质效应。结果全部满足要求。
结论：该结果为支持未来临床 TDM 和合理用药研究提供了重要信息。所提出的方法还为 TDM 和药代动力学研究提供了一种简单、可靠、特异性和合适的技术。
关键词：UPLC、串联质谱、抗精神病药物、治疗药物监测、个体化治疗
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