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用于定量测定人血浆中卡比沙明的简易高效液相色谱法:在药代动力学研究和治疗药物监测中的应用

Simple HPLC Method for Quantitative Determination of Carbinoxamine in Human Plasma: Application in Pharmacokinetic Studies and Therapeutic Drug Monitoring.

作者信息

El-Masry Soha M, El-Morsi Rasha M

机构信息

Department of Pharmaceutics, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt.

Department of Microbiology and Immunology, Faculty of Pharmacy, Suez Canal University, Egypt.

出版信息

Drug Res (Stuttg). 2019 Jun;69(6):342-347. doi: 10.1055/a-0787-1302. Epub 2019 Jan 18.

Abstract

A sensitive, specific and cost-effective HPLC method was developed for quantitative determination of carbinoxamine in human plasma using liquid chromatography with ultraviolet detection. A simple liquid-liquid extraction by ethyl acetate was used to extract carbinoxamine from human plasma. Satisfactory separation was achieved by a mobile phase consisting of 20 mM ammonium dihydrogen orthophosphate containing 0.01% triethyl amine (pH adjusted to 3 by using phosphoric acid) and acetonitrile in ratio of (75:25, v/v) at a flow rate of 0.9 mL/min on Hypersil® BDS C18 column (250×4.6 mm, 5 μm) column. The UV detector was set at 260 nm. The developed method was validated in human plasma with a lower limit of quantitation of 5 ng/mL for carbinoxamine. Linearity was demonstrated over the concentration range 5-200 ng/mL. The observed within- and between-day assay precision ranged from 1.902 to 14.90%; accuracy varied between 98.87 and 108.0%. This method can be used suitably for pharmacokinetic studies and in therapeutic drug monitoring in patients treated with carbinoxamine.

摘要

建立了一种灵敏、特异且经济高效的高效液相色谱法,采用液相色谱-紫外检测法定量测定人血浆中的卡比沙明。采用乙酸乙酯进行简单的液-液萃取从人血浆中提取卡比沙明。在Hypersil® BDS C18柱(250×4.6 mm,5μm)上,以20 mM磷酸二氢铵(含0.01%三乙胺,用磷酸调pH至3)和乙腈按(75:25,v/v)比例组成的流动相,流速为0.9 mL/min,实现了满意的分离。紫外检测器设定在260 nm。所建立的方法在人血浆中进行了验证,卡比沙明的定量下限为5 ng/mL。在5-200 ng/mL浓度范围内证明了线性关系。观察到的日内和日间测定精密度范围为1.902%至14.90%;准确度在98.87%至108.0%之间变化。该方法可适用于卡比沙明治疗患者的药代动力学研究和治疗药物监测。

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