高效液相色谱法测定盐酸博来霉素的有关物质和组分  

Determination of content of bleomycin hydrochloride and its related substances by HPLC

作　　者：鲁瑞娟[1] 杨倩[1] 曹晓云[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《中国抗生素杂志》2015年第5期350-353,共4页Chinese Journal of Antibiotics

基　　金：中国食品药品检定研究院中青年发展研究课题(No.2013WA3)

摘　　要：目的建立盐酸博来霉素有关物质和组分的分析方法。方法采用C18(250mm×4.6mm,5μm)色谱柱,己烷磺酸钠溶液(取己烷磺酸钠7.53g与乙二胺四醋酸二钠3.72g,加0.08mol/L醋酸溶液使溶解并稀释至1000m L,用氨溶液调节p H值至4.3)为流动相A,甲醇—乙腈(7:3)为流动相B,梯度洗脱,检测波长为254nm。结果博来霉素A2和B2分别与相邻杂质峰分离符合规定,盐酸博来霉素的检出限为20ng。结论本法专属﹑灵敏,可作为盐酸博来霉素有关物质和组分的测定方法。Objective To establish an HPLC method for the determination of content of bleomycin hydrochloride and its related substances. Methods A C18（250mm×4.6mm, 5μm） column was used. The mobile phase consisted of sodium hexane sulfonate and EDTA-2Na （pH4.3, adjusted with ammonia） as mobile phase A and methanol-acetonitrile（7：3） as mobile phase B. Gradient elution was used, the detection wavelength was 254nm. Results Bleomycin A2 and B2 could beseparated from the other impurities respectively. Limit of detection for bleomycin hydrochloride was 20ng. Conclusion The method was specific and sensitive. The method could be used for the determination of content of bleomvcin hvdrochloride and its related ,suhstanaes.

关 键 词：盐酸博来霉素 有关物质 组分 

分 类 号：R917[医药卫生—药物分析学]