高效液相色谱-蒸发光散射检测法测定硫酸庆大霉素注射剂中有关物质  

Determination of Related Substances in Gentamycin Sulfate Injection by HPLC-ELSD

作　　者：高燕霞[1] 姜建国[1] 张西如[1] 

机构地区：[1]河北省药品检验所,河北石家庄050011

出　　处：《中国药业》2010年第6期20-21,共2页China Pharmaceuticals

基　　金：河北省科技厅课题;项目编号:042761446

摘　　要：目的建立硫酸庆大霉素注射剂中有关物质的高效液相色谱-蒸发光散射检测(HPLC-ELSD)方法。方法色谱柱采用耐酸Apollo C18柱(250mm×4.6mm,5μm),以0.2mol/L三氟醋酸溶液-甲醇(94∶6)为流动相,蒸发光检测器的漂移管温度为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,可用外标法测定硫酸小诺霉素和硫酸西索米星的含量。结论所用方法准确、灵敏度高,可有效地控制药品质量。Objective To establish a method for the determination of Gentamycin Sulfate Injection related substances by HPLC-ELSD. Methods The Apollo C18 column （250mm×4.6mm,5μm） was used. The mobile phase was 0. 2 mol/L trifluoroacetic acid（TFA）- methanol（94 ： 6）, the detector was evaporative light scattering detector（ELSD）. The temperature of drift tube was 110℃, and the flow rate of carrier gas was 2.0 L/rain. Results Gentamycin sulfate was completely separated from its related substances in the injection. The external reference method was used to quantitate the assay of micronomicin sulfate and sisomicin sulfate. Conclusion The method is accurate, highly specific and widely applicable, which can control the quality of this drug effectively.

关 键 词：硫酸庆大霉素注射剂 高效液相色谱-蒸发光散射检测法 有关物质 硫酸小诺霉素 硫酸西索米星 

分 类 号：R927.11[医药卫生—药学] R978.12