高效液相色谱法测定多西他赛原料药的含量

Determination of Docetaxel Drug Substance by HPLC

目的建立测定多西他赛原料药含量的方法。方法色谱柱为Kromasil C18(5μm,250mm×4.60mm),流动相:甲醇-水(75∶25),流速:1.0mL/min,检测波长:232nm。结果多西他赛原料药在高温、酸性和碱性条件下很不稳定,在氧化剂和光照条件下比较稳定,空白对照均无干扰;多西他赛浓度19.85~29.75μg/mL的范围内呈良好线性(r=0.9995),定量限为0.19μg/mL,检测限为0.052μg/mL,回收率在99.62%~100.06%之间,RSD为0.14%。结论该方法操作简便、灵敏、准确度高,可用于多西他赛原料药的质量控制。

Objective To establish a method for determination of docetaxel drug substances.Methods The analysis was performed on Kromasil C18 column（250 mm×4.6mm,5μm） with detective wave length at232 nm.The mobile phase consisted of a mixture of methanol and water（75∶ 25） with the flow rate of 1.0ML/min.Results Docetaxel drug substance is not stable in the high temperature,acidic and alkaline conditions,but is relatively stable in the oxidant and light conditions.There is no interference in the blank control.Docetaxel concentration of 19.85μg/mL to 29.75μg/mL showed good linearity（r=0.9995）.The limit of quantification was 0.19μg/mL and the detection limit is 0.052μg/mL.The recovery rate was 99.62%~100.06% and RSD0.14%.Conclusion This method is simple,sensitive,accurate and available for quality control of docetaxel drug substance.