| HPLC法测定氯法拉滨原料药中有关物质的含量 |
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| 引用本文： | 孟德胜,;傅若秋,;张蓉,;卢来春. HPLC法测定氯法拉滨原料药中有关物质的含量[J]. 中国药房, 2009, 0(31): 2461-2462 |
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| 作者姓名： | 孟德胜, 傅若秋, 张蓉, 卢来春 |
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| 作者单位： | [1]第三军医大学大坪医院,重庆市400042; [2]第三军医大学新桥医院,重庆市400037 |
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| 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。
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| 关 键 词： | 氯法拉滨 有关物质 高效液相色谱法 含量 |
Content Determination of the Related Substances in Clofarabine Crude Drug by HPLC |
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| Affiliation: | MENG De-sheng, FU Ruo-qiu, LU Lai-chun, ZHANG Rong(The Daping Hospital, The Third Military Medical University, Chongqing 400042, China;The Xinqiao Hospital, The Third Military Medical University, Chongqing 400037, China) |
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| Abstract: | 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. |
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| Keywords: | Clofarabine Related substances HPLC Content |
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