离子抑制色谱法测定琥乙红霉素含量及有关物质

雷嘉川; 梅之南; 余建清; 蔡鸿生; 罗顺德; 张玉蓉

离子抑制色谱法测定琥乙红霉素含量及有关物质

DETERMINATION OF ERYTHROMYCIN ETHYLSUCCINATE AND ITS RELATED SUBSTANCES BY ION SUPPRESSION CHROMATOGRAPHY

摘要

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)℃。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　本法可用于琥乙红霉素原料的含量测定和有关物质的检查。

Abstract: AIM　To develop a method for the determination of erythromycin ethylsuccinate (EES) and its related substances by ion suppression chromatography (ISC), and investigate the influence factors on ISC. METHODS　A Zorbax SB-C₁₈ column was used. The mobile phase was 0.02 mol.L^-1 KH₂PO₄-acetonitrile (45∶55, adjusted to pH 6.8 with aqueous ammonia) and the flow rate was 1.2 mL.min^-1. The UV detection wavelength was 210 nm. The column temperature was maintained at (30±0.5)℃. RESULTS　The composition of mobile phase showed the greatest influence on retention and selectivity, EES was relatively stable in acetonitrile. The main component, erythromycin A ethylsuccinate and its related substances were separated and assayed by ISC, the average recovery of erythromycin A ethylsuccinate was 99.45% (RSD=2.24%, n=5). CONCLUSION　The method can be used to analyze EES.

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