对药典标准中测定红霉素组分及有关物质色谱条件的优化

目的：通过比较红霉素和乳糖酸红霉素两种《中国药典》2010年版拟定标准的色谱条件，并用两种色谱条件测定红霉素组分及有关物质，建议改进《中国药典》2010年版拟定标准中测定红霉素组分及有关物质的色谱条件。方法：采用高效液相色谱法。结果：红霉素A组分在两种色谱条件下测定结果基本一致，红霉素有关物质在乳糖酸红霉素的条件下相对于原条件检出高出10％～20％。结论：乳糖酸红霉素的色谱条件的杂质检出率高，可以更好地控制红霉素的产品质量，而且色谱条件更简单易行。

Optimization of Chromatographic Conditions of Pharmacopoeia Standards for the Determination of Erythromyein and Related Substances

Objective： Comparison of two methods in Preparation of the 2010 edition of Pharmacopoeia standards of erythromycin and erythromycin lactobionate and determination of these two methods with erythromycin and related substances , it is proposed to improve the method in Preparation of the 2010 edition of Pharmacopoeia standards of erythromycin. Method ： Determination of erythromycin and related substances by HPLC. Result： Erythromycin A in the two chromatographic conditions are basically the same results, erythromycin related substances determined with the erythromycin lactobionate conditions are 10% -20% more than that with the Original conditions. Conclusion： Detection rate of impurities in erythromycin lactobionate chromatographic conditions are higher than erythromycin . can better control the product quality, and chromatographic conditions were easier.