阿奇霉素有关物质测定方法的优化  

Development and optimization the method for determination the related substances of azithromycin

作　　者：寇晋萍[1] 王国兰[1] 王俊秋[1] 周立春[1] 

机构地区：[1]北京市药品检验所,北京100035

出　　处：《中国抗生素杂志》2011年第5期360-365,共6页Chinese Journal of Antibiotics

基　　金：国家科技支撑项目(2008BAI55B04-2-1)"药品注射剂检测技术体系研究"

摘　　要：目的对阿奇霉素有关物质测定方法进行优化。方法采用SHISEIDOCAPCELLPAKC18MGII（5μm，4．6mm×250mm）色谱柱；磷酸盐缓冲液（0．05mol／L磷酸氢二钾溶液，用20％的磷酸调节pH值至8．2）：乙腈（45：55）为流动相；柱温30℃；流速1．0mL／min；检测波长210nm。结果阿奇霉素在10-1000μg／mL范围内浓度与峰面积呈良好线性关系，r=0．9999；最低检测限为100ng，与其已知杂质分离度良好。结论本方法可用于测定阿奇霉素及制剂的有关物质。Objective To optimize the method to determination the related substances of azithromycin. Methods A SHISEIDO CAPCELL PAK C18 MG II （5μm, 4.6mm×250mm） column was used. The mobile phase consisted of 0.05mol/L K2HPO4 solution （pH8.2, adjust with 20% phosphate acid）： acetonitrile （45： 55）, the flow rate was 1.0mL/min, the detection wavelength was 210nm. The column temperature was 30℃. Results The calibration curves were linear in the range of 10-1000μg/mL（r=0.9996） for azithromycin, The minimal detection limit was 100ng, and its related substance can be well separated. Conclusion The selective and reliable method can be used for related substances in azithromycin.

关 键 词：阿奇霉素 高效液相色谱法 有关物质 

分 类 号：R917[医药卫生—药物分析学]