阿奇霉素颗粒剂中常用辅料对其HPLC有关物质分析方法的影响  

The effects of excipients on HPLC analysis of azithromycin granule for impurity testing

作　　者：张斗胜[1] 王立新[1] 姚蕾[1] 李娅萍[1] 胡昌勤[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国抗生素杂志》2013年第11期840-843,I0008,共5页Chinese Journal of Antibiotics

摘　　要：目的通过对阿奇霉素颗粒剂中常用辅料的分析,考察其对法定HPLC法分析颗粒剂中阿奇霉素杂质的影响。方法采用中国药典2010年版二部方法,HPLC-DAD检测分析各辅料的色谱、紫外光谱。结果在检测波长210nm下,颗粒处方中的填充剂在色谱检测范围内无吸收峰;崩解剂、表面活性剂、助流剂和甜昧剂出峰位置的相对保留时间均小于0.15,在中国药典2010版规定的辅料峰出峰范围内;矫味剂如苹果香精、椰子香精虽与阿奇霉素GX(EP-H)的保留时间较接近,但其紫外光谱存在明显区别,苹果香精紫外曲线的最大吸收峰为223.4nm,椰子香精紫外曲线的最大吸收峰为199.8、276.8和321.2nm,而阿奇霉素GX呈阿奇霉素的典型吸收曲线,为末端吸收。结论国产阿奇霉素颗粒剂处方添加的诸辅料不影响法定HPLC法对阿奇霉素杂质的检查。Objective Based on the analysis of azithromycin granules of commonly used materials, evaluation of the effects of the excipients on the official HPLC method for impurity control. Method Using the HPLC method of Chinese pharmacopoeia 2010 edition （Chp2010）, all of the excipients of chromatography and ultraviolet spectrum was determined by HPLC-DAD. Result Under the detection wavelength of 210nm, no peaks was detected in the chromatogram when injecting all of the fillers used in azithromyicn granules; the relative retention times including disintegrating agents, surfactants, glidant and sweet ignorant agent were less than 0.15, which complies with Chp2010; the retention times of flavoring agents such as apple flavor and coconut flavor were closer to the retention time of azithromycin GX （EP-H）, but the ultraviolet spectrum of the flavoring agents have a significant difference with the azithromycin GX. the ）Lmax of apple flavor is at about 223.4nm, the ~＂max of Coconut flavor is at about 199.8, 276.8 and 321.2nm, while azithromycin GX were azithromycin typical absorption curve, to end absorption, it is easily to distinguished each other. Conclusion Azithromycin granule added the materials do not affect the legal method of HPLC for impurity testing.

关 键 词：阿奇霉素颗粒剂 常用辅料 HPLC分析法 杂质控制 

分 类 号：R978.15[医药卫生—药品]