高效液相色谱法测定硫酸卷曲霉素的有关物质  

Determination of Related Substances of Capreomycin Sulfate by HPLC

作　　者：陈汝红[1] 孙婷[1] 张艳艳[2] 

机构地区：[1]河北省药品检验所,河北石家庄050011 [2]河北省唐山市药品检验所,河北唐山063000

出　　处：《中国药业》2010年第18期50-51,共2页China Pharmaceuticals

摘　　要：目的建立测定硫酸卷曲霉素及其粉针剂有关物质的高效液相色谱(HPLC)法。方法采用Gemini C18柱(150 mm×4.6 mm,5μm),以0.016 mol/L己烷磺酸钠溶液-甲醇-乙腈-冰醋酸(60∶30∶8∶2)为流动相,检测波长为268 nm。结果卷曲霉素Ⅰ峰和卷曲霉素Ⅱ峰分别与相邻杂质峰分离较好,卷曲霉素Ⅰ的检测限为2 ng。结论 HPLC法简便易行、专属性强、灵敏度高,可用于硫酸卷曲霉素及其粉针剂的有关物质测定。Objective To establish a HPLC method for the determination of related substances of capreomycin sulfate and its injectable power. Methods The C18 column was used with the mixture of 0. 016 mol/L sodium hexanesulfonate solution -methanol -acetonitrile -glacial acetic acid （60 ： 30 ： 8 ： 2） as the mobile phase. The detection wavelength was 268 rim. Results The peaks of capreomycin I and of capreomycin Ⅱ could be separated from the peak of neighboring impurities respectively, the detection limit for capreomycin I was 2 ng. Conclusion The method is simple, specific and sensitive ,which can be used for the determination of related substances of capreomycin sulfate and its injectable power.

关 键 词：硫酸卷曲霉素 有关物质 高效液相色谱法 

分 类 号：R927.11[医药卫生—药学] R978.16