高效液相色谱法测定多西他赛的有关物质  

Determination of the related substances in Docetaxel for drug materials by HPLC

作　　者：楼永明[1] 黄祖斌[2] 

机构地区：[1]福建省药品检验所,福州350001 [2]福建中医药大学,06药学福州350108

出　　处：《海峡药学》2011年第9期41-44,共4页Strait Pharmaceutical Journal

摘　　要：目的建立高效液相色谱法测定多西他赛的有关物质。方法采用HPLC法,色谱柱为Luna C18（5μm,4.6×250mm）,以0.043mol.L-1醋酸铵溶液为流动相A,乙腈为流动相B,按梯度洗脱,流速为1mL.min-1,检测波长为227nm。结果多西他赛浓度在0.02mg.mL-1~0.2mg.mL-1范围内与峰面积有良好的线性关系（r=1.000）。测定样品显示较好的重现性,精密度好（RSD=0.24%）,有关物质的检查限量为1.5%,单个杂质限量为0.5%。结论所建方法准确、简便,使用于多西他赛原料药的质量控制。OBJECTIVE To establish a method for determinate of the related substances in Docetaxel for drug materials.METHODS An HPLC was adopted the related substances determination in Docetaxel using a Luna C18（5μm,4.6×250mm）with UV detection at 227 nm.And the mobile phase A was ammonium acetate solution by 0.043mol·L-1,the mobile phase B was acetonitrile,adopted grads elution,The flow rate was 1.0mL·min-1.RESULTS The test of repeatability was all right,The limit of related substances was 1.5%,and the limit of single impurity was 0.5%.CONCLUSION This method is accurate,simple and effective for the determination of the related substances in Docetaxel for drug materials.This method is suitable for quality control of Docetaxel for drug materials.

关 键 词：多西他赛原料药 HPLC 有关物质 

分 类 号：R927.2[医药卫生—药学]