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.
出处
《海峡药学》
2011年第9期41-44,共4页
Strait Pharmaceutical Journal
