摘要
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-ODSC18,流动相为乙腈-乙酸铵溶液(10:90),流速为1.0mL.min-1,检测波长为262nm,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。
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 C18 column with mobile phase consisted 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 20μL. 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%, respectively. CONCLUSION： This method is simple, sensitive and reproducible, and it is applicable for the determination of the related substances in the clofarabine crude drug.
出处
《中国药房》
CAS
CSCD
北大核心
2009年第31期2461-2462,共2页
China Pharmacy
