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用于卡马西平定量的高效液相色谱法与化学发光微粒子免疫分析法的比较。

Comparison of a high-performance liquid chromatography method for quantification of carbamazepine with chemiluminescent microparticle immunoassay.

作者信息

Guerrero Garduño Óscar, González-Esquivel Dinora F, Escalante-Membrillo Carmen, Fernández Ángeles, Rojas-Tomé Irma Susana, Jung Cook Helgi, Castro Nelly

机构信息

Facultad de Química, Universidad Nacional Autónoma de México, México D.F., Mexico.

Instituto Nacional de Neurología y Neurocirugía, México D.F., Mexico.

出版信息

Biomed Chromatogr. 2016 Jun;30(6):933-7. doi: 10.1002/bmc.3631. Epub 2015 Nov 11.

Abstract

Carbamazepine is an antiepileptic drug widely used for the treatment of epilepsy. In the National Institute of Neurology, monitoring has been performed using the technique chemiluminescent microparticle immunoassay (CMIA) in an automated way during the last five years. The aim of this study was to develop a simple and rapid HPLC analytical method coupled to DAD-UV detection for the determination of plasma concentrations of carbamazepine and compare its feasibility with those used in routine analysis. The developed HPLC method was fully validated and the applicability of the proposed method was verified through the analysis of plasma samples of patients and later compared with the quantification of the same plasma samples with the CMIA method. The limit of quantification obtained was 0.5 μg/mL. The mean value for recovery was 99.05% and the coefficient of variation (CV) was 5.6%. The precision and accuracy of this method were within the acceptable limits; inter- and intraday CV values were <10%. The correlation between the CMIA method and the developed HPLC method was very good (r ≈ 0.999). A Bland-Altman plot showed no significant bias between the results. The HPLC-DAD method may be an alternative to determine and monitoring the carbamazepine levels in human plasma or serum. Copyright © 2015 John Wiley & Sons, Ltd.

摘要

卡马西平是一种广泛用于治疗癫痫的抗癫痫药物。在国立神经病学研究所,过去五年一直采用化学发光微粒子免疫分析(CMIA)技术进行自动化监测。本研究的目的是开发一种简单快速的高效液相色谱(HPLC)分析方法,结合二极管阵列紫外(DAD-UV)检测来测定卡马西平的血浆浓度,并将其可行性与常规分析方法进行比较。所开发的HPLC方法经过了全面验证,并通过分析患者的血浆样本验证了该方法的适用性,随后将其与采用CMIA方法对相同血浆样本进行定量的结果进行比较。得到的定量限为0.5μg/mL。回收率的平均值为99.05%,变异系数(CV)为5.6%。该方法的精密度和准确度在可接受范围内;日间和日内CV值均<10%。CMIA方法与所开发的HPLC方法之间的相关性非常好(r≈0.999)。Bland-Altman图显示结果之间无显著偏差。HPLC-DAD方法可作为测定和监测人血浆或血清中卡马西平水平的一种替代方法。版权所有©2015约翰威立父子有限公司。

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