HPLC-ELSD法测定硫酸庆大霉素中的有关物质  

Determination of related substances in gentamycin sulfate by HPLC-ELSD

作　　者：高燕霞[1] 姜建国[1] 韩彬[1] 

机构地区：[1]河北省药品检验所,河北石家庄050011

出　　处：《中国当代医药》2009年第20期21-22,共2页China Modern Medicine

基　　金：2004年河北省科技厅课题(项目编号:042761446)

摘　　要：目的:本文建立了硫酸庆大霉素有关物质的HPLC-ELSD测定方法。方法:使用耐酸C18柱,0.2mol/L三氟醋酸溶液∶甲醇(94∶6)为流动相;采用蒸发光检测器:漂移管温度为110℃,载气流量为2.0L/min。结果:硫酸庆大霉素与有关物质分离完全,并利用外标法定量测定硫酸小诺霉素和硫酸西索米星。结论:方法准确、灵敏度高,本方法可有效地控制药品质量。Objective： To establish a method for determination of gentamicin sulfate related substance by HPLC-ELSD Methods： A C18 column was used, the mobile phase was 0.2 mol/L TFA-methanol （94：6）, the detecter was ELSD. The tem- perature of drift tube was 110℃, and flow rate of carrier gas was 2.0 L/min. Results： The gentamicin sulfate was separated from its related substance completely.The extemal reference method was used to quantitative the assay of micronomicin sulfate and sisomicin sulfate. Conclusion： The method is accurate,highly specific and widely applicable.It can control the quality of drug effectively.

关 键 词：硫酸庆大霉素 HPLC—ELSD 有关物质 硫酸小诺霉素 硫酸西索米星 

分 类 号：R914.1[医药卫生—药物化学]