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采用非接触式电导检测的经济高效毛细管电泳法用于β-内酰胺类抗生素的质量控制。

Cost-effective capillary electrophoresis with contactless conductivity detection for quality control of beta-lactam antibiotics.

机构信息

Department of Analytical Chemistry, Faculty of Chemistry, VNU University of Science, Vietnam National University-Hanoi, 19 Le Thanh Tong, Hanoi, Viet Nam.

Department of Analytical Chemistry, Faculty of Chemistry, VNU University of Science, Vietnam National University-Hanoi, 19 Le Thanh Tong, Hanoi, Viet Nam.

出版信息

J Chromatogr A. 2019 Nov 8;1605:360356. doi: 10.1016/j.chroma.2019.07.010. Epub 2019 Jul 15.

DOI:10.1016/j.chroma.2019.07.010
PMID:31327480
Abstract

A simple and inexpensive approach for determination of various antimicrobial drugs using a purpose-made compact capillary electrophoresis (CE) instrument with capacitively coupled contactless conductivity detection (CD) is reported. The objective of the work is to propose an affordable and easily-implemented tool for quality control and detection of counterfeiting of antibiotic formulations in resource constrained developing countries. The design of the purpose-made CE-CD system was improved according to the feedback from over 10 years of use of our previous instrument. CE-CD methods were for the first time developed to analyze β-lactam-based antibiotics commonly used in Vietnam, including single- β-lactam antibiotics (i.e. Cephalexin, Cefotaxime Sodium, Cefixime and Sulbactam) as well as β-lactams co-formulated with Sulbactam (i.e. Amoxicillin, Ampicillin, Cefoperazone and Sulbactam). Single β-lactam antibiotics were analyzed using a background electrolyte (BGE) composed of Tris/Ace (10 mM, pH 7.8) whereas β-lactam - Sulbactam combinations were simultaneously separated using a BGE containing Tris/Ace (10 mM, pH 7.5). The best achieved detection limits were 2.0 mg/L and 1.0 mg/L for these two groups, respectively. Good agreement between results obtained from CE-CD and standard confirmation methods (LCMS) was achieved, with a coefficient of determination, r, of 0.9991. The applicability of the developed CE-CD method was demonstrated for quality control of 24 β-lactam-based antimicrobial drugs available in Vietnam.

摘要

本文报道了一种使用专用紧凑型毛细管电泳(CE)仪与电容耦合非接触电导检测(CD)相结合,可用于测定多种抗菌药物的简单、经济的方法。该工作的目的是为资源有限的发展中国家提出一种负担得起且易于实施的工具,用于对抗生素制剂的质量控制和假冒伪劣产品的检测。根据我们之前的仪器使用 10 多年的反馈,对专用 CE-CD 系统的设计进行了改进。首次为分析在越南常用的基于β-内酰胺的抗生素开发了 CE-CD 方法,包括单-β-内酰胺抗生素(即头孢氨苄、头孢噻肟钠、头孢克肟和舒巴坦)以及与舒巴坦联合的β-内酰胺抗生素(即阿莫西林、氨苄西林、头孢哌酮和舒巴坦)。单-β-内酰胺抗生素采用 Tris/Ace(10 mM,pH 7.8)组成的背景电解质(BGE)进行分析,而β-内酰胺-舒巴坦组合则采用含有 Tris/Ace(10 mM,pH 7.5)的 BGE 同时分离。这两组的最佳检测限分别为 2.0 mg/L 和 1.0 mg/L。CE-CD 与标准确证方法(LCMS)获得的结果之间具有良好的一致性,决定系数 r 为 0.9991。该方法已应用于对越南市售 24 种基于β-内酰胺的抗菌药物进行质量控制。

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