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液相色谱法测定琥乙红霉素

Determination of erythromycin ethylsuccinate by liquid chromatography.

作者信息

Cachet T, Lannoo P, Paesen J, Janssen G, Hoogmartens J

机构信息

Katholieke Universiteit Leuven, Laboratorium voor Farmaceutische Chemie, Belgium.

出版信息

J Chromatogr. 1992 May 27;600(1):99-108. doi: 10.1016/0021-9673(92)85443-w.

Abstract

A method is described for the determination of erythromycin ethylsuccinate by liquid chromatography. A C18 reversed-phase column (25 cm x 4.6 mm I.D.) was used with acetonitrile-0.2 M tetrabutylammonium sulphate (pH 6.5)-0.2 M phosphate buffer (pH 6.5)-water [x:5:5:(90-x)] as mobile phase. The proportion of acetonitrile (x) has to be adapted to the type of stationary phase used. For RSil C18 LL, 42.5% was used. The column was heated at 35 degrees C, the flow-rate was 1.5 ml/min and UV detection was performed at 215 nm. The main component, erythromycin A ethylsuccinate, was separated from all other components which were present in commercial samples. The main impurities were erythromycin A and the ethylsuccinate esters of erythromycin B and C. The amide N-ethylsuccinyl-N-demethylerythromycin A was shown to be present in all the samples examined. The method was successfully applied to the analysis of specialities.

摘要

描述了一种通过液相色谱法测定琥乙红霉素的方法。使用C18反相柱(25 cm×4.6 mm内径),以乙腈-0.2 M硫酸四丁铵(pH 6.5)-0.2 M磷酸盐缓冲液(pH 6.5)-水[x:5:5:(90-x)]作为流动相。乙腈(x)的比例必须根据所用固定相的类型进行调整。对于RSil C18 LL,使用的比例为42.5%。柱温加热至35℃,流速为1.5 ml/min,在215 nm处进行紫外检测。主要成分琥乙红霉素A与市售样品中存在的所有其他成分分离。主要杂质为红霉素A以及红霉素B和C的琥乙酯。在所检测的所有样品中均显示存在酰胺N-乙基琥珀酰-N-去甲基红霉素A。该方法成功应用于制剂分析。

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