HPLC测定盐酸噻氯匹定中的有关物质  

Determination of the related substances in Hydrochloride ticlopidine by HPLC

作　　者：张煜辉 唐鹤松 

机构地区：[1]成都蓉药集团四川长威制药有限公司,四川乐山614006

出　　处：《华西药学杂志》2014年第5期589-590,共2页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用HPLC法测定盐酸噻氯匹定中的有关物质。方法采用Zorbax XDB C8色谱柱,以缓冲液-甲醇（70∶30）为流动相,检测波长220 nm,流速1.2 mL·min^-1,柱温40℃。结果主成分峰与各杂质峰可完全分离,杂质F 0.06‰～1.5‰与峰面积呈良好的线性关系（r=0.9998）,平均回收率为98.76%,RSD=5.73%（n=3）,最低检出量为0.1 mg·L^-1。结论所用方法专属性强,可用于盐酸噻氯匹定中有关物质的检测。OBJECTIVE To establish an HPLC method to determinate the related substances of Hydrochloride ticlopidine. METH- ODS The separation was performed by a Zorbax XDB C8 column with buffer - methanol （70 ： 30） as mobile phase. The detection wavelength was 220 nm, the flow rate was 1.2 mL·min^ -1 and the column temperature was 40℃. RESULTS Ticlopidine was com- pletely separated from other impurities. The calibration curve was linear in the range of 0.06%v - 1.5%0（ r = 0. 9998 ） , as well as the average recovery rate was 98.76% and the RSD was 5.73 % （ n = 3 ）, and the LOD was 0.1 mg· L ^- 1. CONCOLUSION The method has strong specifiety, and could be applied to determine the related substances of Hydrochloride ticlopidine.

关 键 词：盐酸噻氯匹定 高效液相色谱法 有关物质 

分 类 号：R917[医药卫生—药物分析学]