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Article

Development and Validation of a Highly Sensitive and Rapid LC-MS3 Strategy to Determine Oxcarbazepine and Its Active Metabolite in the Serum of Patients with Epilepsy and Its Application in Therapeutic Drug Monitoring

by
Zhengchao Ji
1,†,
Tingting Li
2,†,
Xin Zhao
3,
Wei Ma
4,
Yanyan Li
1,* and
Jing Huang
1,*
1
Department of Laboratory Medicine, The First Hospital of Jilin University, Jilin University, Changchun 130021, China
2
Vascular Surgery, General Surgery Center, The First Hospital of Jilin University, Jilin University, Changchun 130021, China
3
Department of Health Examination Center, The First Hospital of Jilin University, Jilin University, Changchun 130021, China
4
Department of Pharmacy, The First Hospital of Jilin University, Jilin University, Changchun 130021, China
*
Authors to whom correspondence should be addressed.
†
These authors contributed equally to this work.
Molecules 2022, 27(17), 5670; https://doi.org/10.3390/molecules27175670
Submission received: 17 July 2022 / Revised: 26 August 2022 / Accepted: 29 August 2022 / Published: 2 September 2022
(This article belongs to the Section Analytical Chemistry)
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Abstract

A sensitive and rapid bioanalytical method based on the LC-triple-stage fragmentation (LC-MS3) strategy on a hybrid triple quadrupole-linear ion trap mass spectrometer in combination with protein precipitation extraction for sample pretreatment has been developed and validated for the simultaneous determination of the antiepileptic drug oxcarbazepine (OXC) and its main active metabolite (MHD) in human serum. The separation was performed on a Waters XBridge BEH C18 column (2.5 µm, 2.1 × 50 mm) in isocratic elution with 0.1% formic acid in water and methanol (50:50, v:v) as the mobile phase. The run time for each sample was 2.0 min. The calibration curves ranging from 25 to 1600 ng/mL for OXC and from 0.5 to 32 μg/mL for MHD showed correlation coefficients (r) better than 0.99. All of the validation data, such as precision, accuracy and other parameters, fit the requirements of the current bioanalytical method validation guidelines. The LC-MS3 method for quantitation of OXC and MHD was compared with the LC-MRM based method. Passing–Bablok regression coefficients and Bland–Altman plots showed that the developed LC–MS3 method is a reliable method for quantitative analysis of OXC and MHD. The proposed LC-MS3 method was successfully applied to determine the serum concentrations of OXC and MHD to support a clinical study.
Keywords: oxcarbazepine; 10-hydroxycarbazepine; LC-MS3; validation; therapeutic drug monitoring oxcarbazepine; 10-hydroxycarbazepine; LC-MS3; validation; therapeutic drug monitoring

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MDPI and ACS Style

Ji, Z.; Li, T.; Zhao, X.; Ma, W.; Li, Y.; Huang, J. Development and Validation of a Highly Sensitive and Rapid LC-MS3 Strategy to Determine Oxcarbazepine and Its Active Metabolite in the Serum of Patients with Epilepsy and Its Application in Therapeutic Drug Monitoring. Molecules 2022, 27, 5670. https://doi.org/10.3390/molecules27175670

AMA Style

Ji Z, Li T, Zhao X, Ma W, Li Y, Huang J. Development and Validation of a Highly Sensitive and Rapid LC-MS3 Strategy to Determine Oxcarbazepine and Its Active Metabolite in the Serum of Patients with Epilepsy and Its Application in Therapeutic Drug Monitoring. Molecules. 2022; 27(17):5670. https://doi.org/10.3390/molecules27175670

Chicago/Turabian Style

Ji, Zhengchao, Tingting Li, Xin Zhao, Wei Ma, Yanyan Li, and Jing Huang. 2022. "Development and Validation of a Highly Sensitive and Rapid LC-MS3 Strategy to Determine Oxcarbazepine and Its Active Metabolite in the Serum of Patients with Epilepsy and Its Application in Therapeutic Drug Monitoring" Molecules 27, no. 17: 5670. https://doi.org/10.3390/molecules27175670

APA Style

Ji, Z., Li, T., Zhao, X., Ma, W., Li, Y., & Huang, J. (2022). Development and Validation of a Highly Sensitive and Rapid LC-MS3 Strategy to Determine Oxcarbazepine and Its Active Metabolite in the Serum of Patients with Epilepsy and Its Application in Therapeutic Drug Monitoring. Molecules, 27(17), 5670. https://doi.org/10.3390/molecules27175670

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