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J Chromatogr B Analyt Technol Biomed Life Sci. 2019 Apr 1;1112:61-66. doi: 10.1016/j.jchromb.2019.02.027. Epub 2019 Feb 26.

Development and validation of a specific and sensitive LC-MS/MS method for determination of eslicarbazepine in human plasma and its clinical pharmacokinetic study.

Author information

1
Key Laboratory of Drug Quality Control and Pharmacovigilance (China Pharmaceutical University), Ministry of Education, Nanjing 210009, PR China; Department of Pharmaceutical Analysis, School of Pharmacy, China Pharmaceutical University, 24 Tongjiaxiang, Nanjing, 210009, PR China.
2
The Fifth Affiliated Hospital of Zunyi Medical University, Zhuhai 519100, P. R. China.
3
Key Laboratory of Drug Quality Control and Pharmacovigilance (China Pharmaceutical University), Ministry of Education, Nanjing 210009, PR China; Department of Pharmaceutical Analysis, School of Pharmacy, China Pharmaceutical University, 24 Tongjiaxiang, Nanjing, 210009, PR China. Electronic address: shuchang@cpu.edu.cn.

Abstract

In this work, we developed and validated the specific, sensitive and simple LC-MS/MS method for quantification of eslicarbazepine in human plasma. The analyte samples were prepared through a simple one-step protein precipitation method by acetonitrile. The chromatographic separation was operated on an economical Hanbon ODS-2 C18 column (150 mm × 2.1 mm, 10 μm) with isocratic elution using 10 mM ammonium acetate containing 0.01% formic acid and acetonitrile (72:28, v/v) as the mobile phase at the flow rate of 0.5 mL/min. The mass quantification was carried on the multiple reaction monitoring (MRM) of the transitions of m/z 255.1 → 194.1 for eslicarbazepine and m/z 446.1 → 321.1 for glipizide (the internal standard), respectively. The established method was validated with acceptable specificity, linearity, accuracy, precision, extraction recovery, matrix effect and stability in accordance with FDA regulations. At last, the validated method was successfully applied to determination of eslicarbazepine in human plasma obtained from clinical study.

KEYWORDS:

Eslicarbazepine; Human plasma; LC-MS/MS; Pharmacokinetics; Protein precipitation

PMID:
30856604
DOI:
10.1016/j.jchromb.2019.02.027
[Indexed for MEDLINE]

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