UPLC-MS法检测克林霉素磷酸酯葡萄糖注射液高温灭菌后的药物成分  

UPLC-MS Detection of Medicinal Ingrediants in Clindamycin Phosphate Glucose Injection Sterilized with High Temperature

作　　者：樊磊磊[1] 李松武 

机构地区：[1]河南省食品药品检验所,郑州450003 [2]河南省食品药品监督管理局,郑州450003

出　　处：《中国实验方剂学杂志》2011年第24期74-76,共3页Chinese Journal of Experimental Traditional Medical Formulae

摘　　要：目的:检测克林霉素磷酸酯葡萄糖注射液高温灭菌后的药物成分。方法:采用UPLC-MS方法色谱条件:AcquityUPLC BEH C18(2.1 mm×50 mm,1.7μm)色谱柱,流动相乙腈-0.02M醋酸铵缓冲液(醋酸调pH 3.0),梯度洗脱,流速为0.25mL.min-1。质谱条件:电喷雾离子源(ESI),多反应检测(MRM)。结果:高温灭菌后的克林霉素磷酸酯葡萄糖注射液中检测到克林霉素磷酸酯、克林霉素和林可霉素,克林霉素为克林霉素磷酸酯葡萄糖注射液灭菌后的最大杂质。结论:此方法选择性强、灵敏度高,可作为分析灭菌后的克林霉素磷酸酯葡萄糖注射液中药物成分的检测方法。Objective：To establish an UPLC-MS method for the determination of medicinal ingrediants in Clindamycin Phosphate Glucose injection sterilized with high temperature.Method： LC condition： Adopted Acquity UPLC BEH C18column（2.1 mm×50 mm,1.7 μm,eluted gradiently with mobile phase consisted of acetonitrile and 0.02 mol·L-1 ammonium acetate buffer solution adjusted pH 3.0 with acetic acid）at a flow rate 0.25 mL·min-1.MS condition,adopted electrospray ionization（ESI）,and multiple reaction monitoring.Result：Clindamycin phosphate,clindamycin and lincamycin were detected in the clindamycin phosphate glucose injection sterilized with high temperature,and clindamycin is the maxest impurity.Conclusion：This method is selectivity and sensitive,it is suitable for detection of the medicinal ingrediants in clindamycin phosphate glucose injection sterilized with high temperature.

关 键 词：克林霉素磷酸酯葡萄糖注射液 高温灭菌 克林霉素 林可霉素 超高频相色谱-质谱 

分 类 号：R284.1[医药卫生—中药学]