HPLC测定盐酸替罗非班中的有关物质  

Determination of the related substances in Tirofiban hydrochloride by HPLC

作　　者：聂忠莉[1] 蒲旭峰[2] 唐雪枫 陈小宁 杨彩霞[4] 

机构地区：[1]成都大学生物产业学院,四川成都610106 [2]成都市食品药品检测中心,四川成都610045 [3]成都欣捷高新技术有限公司,四川成都610041 [4]成都中医药大学药学院,四川成都611137

出　　处：《华西药学杂志》2015年第5期612-614,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用HPLC法测定盐酸替罗非班原料药中的有关物质。方法色谱柱为Inertsil ODS-3 C18柱（250 mm×4.6mm,5μm）,梯度洗脱,流速1 m L·min-1,柱温30℃,检测波长227 nm,进样量50μL。结果盐酸替罗非班与3种杂质的分离良好,线性范围均为5~5×103ng·m L-1;检测限分别为0.21、0.12、0.18、0.10 ng;以盐酸替罗非班为参比,杂质Ⅰ、Ⅱ、Ⅲ的校正因子分别为1.0、1.4、0.8。结论所用方法专属性强、准确度高,可用于检查盐酸替罗非班原料药中的有关物质。OBJECTIVE To establish an HPLC method to determine the related substances in Tirofiban hydrochloride. METHODS An Intersil ODS -3 C18 column was used. Gradient elution was adopted and the detection wavelength was 227 nm with the flow rate of 1 mL-min-l. Column temperature was 30 ℃ and the injection volume was 50 μL. RESULTS Tirofiban hydrochloride was com- pletely separated from three impurities which potentially existed. The linear ranges of Tirofiban Hydrochloride,impurity Ⅰ , impurity Ⅱ and impurity Ⅲwere 5 -5 ×10^3 ng·mL-1 ,the LOQs were 0. 21,0.12,0.18 and 0.10 ng,respectively. The relative correction factorsof impurity Ⅰ ,impurity Ⅱ and impurity Ⅲ were 1.0,1.4 and 0.8, respectively. CONCLUSION The method is simple, specific, accurate and suitable for analyzing the related substances in Tirofiban hydrochloride.

关 键 词：盐酸替罗非班 有关物质 高效液相色谱法 含量 测定 杂质 校正因子 

分 类 号：R917[医药卫生—药物分析学]