手性流动相高效液相色谱法分析盐酸替罗非班  

HPLC determination of tirofiban using chiral mobile phase

作　　者：尹燕杰[1] 乔蕾[1] 张启明[2] 

机构地区：[1]哈尔滨市食品药品检验检测中心,哈尔滨150525 [2]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2013年第6期1012-1015,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立替罗非班对映体的HPLC手性流动相添加剂拆分方法,测定盐酸替罗非班手性异构体杂质含量。方法:应用高效液相色谱法,以羟丙基-γ-环糊精作为手性流动相添加剂,通过考察影响分离的一些因素,确定替罗非班对映体的分离条件为:以25 mmol.L-1磷酸二氢钾溶液(pH 5.5,含10 mmol.L-1羟丙茎-γ-环糊精)-乙腈(80∶20)为流动相,流速为0.8 mL.min-1,检测波长226 nm。结果:替罗非班对映体的分离度为1.8。将该方法用于盐酸替罗非班的检查,结果手性异构体杂质含量为0.15%。结论:所建立的方法方便地实现了替罗非班对映体的拆分及盐酸替罗非班样品中手性异构体杂质的检测。Objective：To establish an HPLC chiral separation method for tirofiban hydrochloride enantiomers using a chiral mobile phase additive to determine the enantiomeric purity of tirofiban. Method：The HPLC separation was carried out with hydroxypropyl - γ - cgclodextrin （ HP - γ - CD） as the chiral mobile phase additive. The separa-tion condition as follows for tirofiban enantiomers was identified through investigating influencing factors on separa-tion ： a mobile phase of 25 mmol · L^-1 potassium dihydrogen phosphate （ pH 5.5, containing 10 mmol · L^-1 HP - γ - CD） - acetonitrile （ 80： 20） was used, the flow rate was 0. 8 mL · min^ - 1, and the detection wavelength at 226 nm. Results：The enantiomers of tirofiban were separated with a resolution of 1.8. The enantiomeric purity of tirofi-ban hydrochloride was detected as 0. 15% by this method. Conclusion：This simple method realizes the separation of tirofiban enantiomers and the detection of chiral isomer impurities in tirofiban hydrochloride samples.

关 键 词：手性流动相添加剂 环糊精 对映体拆分 替罗非班 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]