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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

Authors Qi Y, Liu G

Received 3 December 2020

Accepted for publication 21 January 2021

Published 12 February 2021 Volume 2021:15 Pages 463—479

DOI https://doi.org/10.2147/DDDT.S290963

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 4

Editor who approved publication: Dr Tuo Deng


Yingjie Qi, Guangxuan Liu

Department of Pharmacy, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, 110042, Liaoning Province, People’s Republic of China

Correspondence: Yingjie Qi
Department of Pharmacy, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Number 44 Xiaoheyan Road, Dadong District, Shenyang, 110042, Liaoning Province, People’s Republic of China
Tel +8618909811762
Email princessqyj@sina.com

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

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