离子抑制色谱法测定琥乙红霉素含量及其有关物质

离子抑制色谱法测定琥乙红霉素含量及其有关物质

余建清, 雷嘉川^*, 罗顺德, 邹国林

1.武汉大学人民医院, 武汉 430060;
2.武汉大学生命科学院, 武汉 430070

收稿日期:2002-09-12 修回日期:2003-02-10 出版日期:2003-03-15 发布日期:2003-03-15
通讯作者: 雷嘉川*

Determination of Erythromycin Ethylsuccinate and its Related Substances by Ion Suppression Chromatography

YU Jian-qing, LEI Jia-chuan^*, LUO Shun-de, ZOU Guo-lin

1.Renmin Hospital, Wuhan University, Wuhan 430060, China;
2.College of Life Sciences, Wuhan University, Wuhan 430072, China

Received:2002-09-12 Revised:2003-02-10 Online:2003-03-15 Published:2003-03-15
Contact: LEI Jia-chuan*

摘要/Abstract

摘要： 目的建立离子抑制色谱法测定琥乙红霉素原料的含量及有关物质的方法, 并研究其影响因素。方法采用Zorbax SB-C18色谱柱, 以0.02 mol·L^-1 KH2PO4-乙腈(45:55, 用氨试液调至pH 6.8)为流动相, 流速1.2 mL·min^-1, 检测波长210 nm , 柱温(30±0.5) °C。结果在选定固定相条件下, 流动相对组分的洗脱和选择性影响最大, 柱温次之, 琥乙红霉素在乙腈中比较稳定。测定了有效主成分琥乙红霉素A的含量以及7个有关物质的总含量, 琥乙红霉素A的平均回收率为99.45%(RSD =2.24 % , n = 5 )。结论本方法可用于琥乙红霉素原料的含量测定和有关物质的检查。

关键词: 琥乙红霉素, 有关物质, 离子抑制色谱法, 测定方法

Abstract: Aim Method for the determination of erythromycin ethylsuccinate(EES) by ion suppression chromatography (ISC) was developed and the influenc factors on ISC were investigated. Methods A Zorbax SB-C18 column was used with 0.02 mol·L^-1 potassium dihydrogen phosphate acetonitrile (45:55) as mobile phase. The pH and proportion of the mobile phase showed the greatest influences on retention and selectivity. Therefore, the pH of mobile was adjusted to 6.8, the best acetonitrile proportion was 55%. The column temperature was maintained at (30±0.5) °C. Acetonitrile was used as solvent for the sample preparation because EES is more stable in it. The flow rate was 1.2 mL·min^-1and UV detection was performed at 210 nm. Results Under these chromatographic conditions, the main component (erythromycin A ethylsuccinate) and its related substances were separated. The calibration curve showed good linearity over the range of 0.1-1.0 mg·mL^-1, and its correlation coefficient was 0.9998. Conclusion The method is very suitable for the analysis of erythromycin ethylsuccinate.

Key words: erythromycin ethylsuccinate, erythromycin ethylsuccinate, related substances, related substances, ion suppression chromatography, ion suppression chromatography, method development, method development

中图分类号:

R917

TQ460.72

Supporting: ^*Corresponding author. Tel.: 13871122393; fax: 86-027-88042292

余建清, 雷嘉川^*, 罗顺德, 邹国林. 离子抑制色谱法测定琥乙红霉素含量及其有关物质[J]. .

YU Jian-qing, LEI Jia-chuan^*, LUO Shun-de, ZOU Guo-lin . Determination of Erythromycin Ethylsuccinate and its Related Substances by Ion Suppression Chromatography[J]. .

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