摘要
目的建立阿奇霉素原料中有机溶剂二氯甲烷、丙酮和乙醇残留量的测定方法。方法采用溶液直接进样气相色谱法,用玻璃柱上附二乙烯苯-乙基乙烯苯型高分子多孔小球作为固定相吸附柱,进样温度140℃,柱温160℃,维持6min,载气为氮气,柱前压为30psi,以氢火焰离子化检测器进行检测,实现了各组分的基线分离。结果3批阿奇霉素原料中有机溶剂残留量均符合规定。结论所用方法灵敏、准确,适用于阿奇霉素原料中有机溶剂残留量的测定。
Objective To determine the contents of residual organic solvents in azithromycin raw material. Methods The GC determination was performed on a glass column which was packed a polymer named divinylbenzene-phenylethylene with FID detection. The injection port and detector temperature were 140℃ and 160℃ ,respectively. The column inlet pressure was 30 psi. Under experiment condition, dichloromethane, acetone, alcohol and benzene were separated thoroughly. Results Three batches of sampies were analyzed by the method. None of residual organic solvent was found to exceed quality limit. Conclusions The method is proved to be accurate and sensitive. It is suitable for the analysis of the residual organic solvents in azithromycin.
出处
《西北药学杂志》
CAS
2007年第1期3-4,共2页
Northwest Pharmaceutical Journal
关键词
阿奇霉素
有机溶剂残留
气相色谱法
azithromycin
residual organic solvent
Gas Chromatography
