HPLC法测定氯法拉滨原料药中有关物质的含量

摘要

OBJECTIVE: To establish an HPLC method for determination of the related substances in clofarabine crude drug. METHODS: The determination of sample was performed on Shim-pack VP-ODS C_(18) column with mobile phase con-sisted of acetonitrile-ammonium acetate solution (10 : 90) at a flow rate of 1.0 mL · min~(-1). The detection wavelength was set at 262 nm and the sample size was 20 μL. A specificity test on the crude drug was performed, and the contents of the related substances in 3 batches of samples were determined by self-control method. RESULTS: The main peaks were distinctive from all the peaks of the foreign substances, and the contents of the related substances were 0.26% , 0.26% and 0.29% , respec-tively. CONCLUSION: This method is simple, sensitive and reproducible, and it is applicable for the determination of the related substances in the clofarabine crude drug.%目的:建立以高效液相色谱法测定氯法拉滨原料药中有关物质含量的方法.方法:色谱柱为Shim-pack VP-ODS C_(18),流动相为乙腈-乙酸铵溶液(10:90),流速为1.0 mL·min~(-1)检测波长为262 nm,进样量为20μL.对原料药进行专属性试验,以自身对照法测定3批原料药中有关物质的含量.结果:3批原料药在专属性试验中主峰与各杂质峰分离良好,有关物质含量分别为0.26%、0.26%、0.29%.结论:本方法简便、灵敏、重复性好,可用于氯法拉滨有关物质含量的测定.