注射用硫酸核糖霉素有关物质的检查  

Studies on the Related Substances of Ribostamycin Sulfate for Injection

作　　者：李晓鑫[1] 姜红 赵亚萍 陈宁林 马长清[1] 

机构地区：[1]华中科技大学同济医学院药学院药物分析教研室,武汉430030 [2]湖北省药品检验所,武汉430064

出　　处：《医药导报》2008年第9期1106-1108,共3页Herald of Medicine

摘　　要：目的建立硫酸核糖霉素有关物质的检测方法。方法采用薄层色谱法,以硅胶G为吸附剂,以2-丁酮-甲醇-异丙醇-浓氨水-水(10:12:3:8:2)为展开剂,用0.2%茚三酮的水饱和正丁醇溶液显色。结果核糖霉素主斑点与新霉胺及其他杂质斑点分离完全;检测限为0.08μg。结论该方法专属性强且操作简便,可用于硫酸核糖霉素及其制剂的有关物质的检查。Objective To establish a method to determine the related substances of ribostamyein for injection. Methods Thin-layer chromatography （TLC） was develop using the silica G as sorbent, a mixture of 2-butanone, methanol, isopropanol,ammonia water and water（10 ： 12 ： 3 ： 8 ： 2）as developing solvent. The samples were colored by 0. 2% triketohydrindene hydrate dissolved in the n-butanol and saturated by water. Results An apparent separation between the principal spot of ribostamycin and the related spots was observed. The detectability was 0.08 μg. Conclusion The method is simple for the quality control of the preparation with a high specificity.

关 键 词：核糖霉素 硫酸 新霉胺 色谱法 薄层 

分 类 号：R927.1[医药卫生—药学] R978.1