HPLC测定注射用多西他赛的含量并检查有关物质

Determination of the content and related substances in Docetaxel for injection by HPLC

目的建立测定注射用多西他赛含量及有关物质的方法。方法采用HPLC法，色谱柱为Luna C18（200mm×4．6mm，5μm），流动相为乙腈-水（50：50），流速为1．0ml·min^-1，检测波长233nm。结果多西他赛浓度1～200μg·ml^-1与峰面积的线性关系良好（r=0．9999），重复性试验的RSD=0．1％（n=6），高、中、低浓度的平均回收率为101．8％，有关物质检查的限量为2．0％，单个杂质限量为1．0％。结论所建方法准确、简便、快速，适用于注射用多西他赛的质量控制。

OBJECTIVE To establish a method for determination of the contents and related substances in Docetaxel for injection.METHODS An HPLC method was adopted. The contents and related substances in Docetaxel for injection were determined by HPLC using a Luna C18 column（200 mm×4. 6 mm, 5 μm）with UV detection at 233 nm. And the mobile phase consisted of acetonitrile and water （50 ： 50）. The flow rate was 1.0 ml·min^-1. RESULTS The calibration curve was linear （ r = 0. 9999 ） within the range of 1 - 200 μg·ml^-1 for DocetaxeL The RSD of repeatability test was 0. 1%. The average recovery rate was 101.8% for three different levels of Docetaxel. The limit of related substances was 2.0% , and the limit of single impurity was 1.0%. CONCLUSION This method is simple, rapid, accurate and effective for the determination of content and related substances in Docetaxel for injection. This method is suitable for quality control of Docetaxel for injection.