摘要
目的研究注射用阿奇霉素制剂中具有刺激性气味的未知杂质成分。方法运用气相色谱-质谱联用技术,结合质谱数据检索对其挥发性未知杂质进行结构鉴定。结果根据阿奇霉素酸性环境下裂解规律,对数据检索结果验证,共鉴定出2个挥发性杂质成分:3-甲基呋喃和2-乙烯基-3-甲基呋喃;其中3-甲基呋喃通过对照品定位确定,2-乙烯基-3-甲基呋喃因无对照品而暂未定量研究。结论本文采用的气相和气质色谱条件,都能方便、快捷的检测到注射用酸性阿奇霉素制剂中含有的挥发性杂质成分,尤其对含挥发性杂质成分较高的硫酸和盐酸成盐的阿奇霉素制剂,因此本研究为酸性阿奇霉素制剂的质量控制提供了重要依据。
Objective To study the unknown chmical constituents in azithromycin for injection. Methods The unknown impurity of the essential volatile were detected by GC-MS in azithromycin for injection, Peaks and their corresponding compounds were identified through database index. Results The two substances were identified as 3-methyl furan and 2-vinyl-3-methyl furan by reference substance and fragmentation regularity of azithromycin in an acid environment. Conclusions The two kinds of essential volatile were convenient, fast to detected by the GC and GC- chromatography conditions in azithromycin for injection, especially for azithromycin sulfate and azithromycin hydrochloride. The method can be used for further identification and quality control of the related substances in azithromycin for injection.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2014年第12期932-936,共5页
Chinese Journal of Antibiotics
