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

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

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。

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.