HPLC法测定富马酸替诺福韦二吡呋酯原料药的有关物质  

Determination of the Related Substance in Tenofovir Disoproxil Fumarate by HPLC

作　　者：李俊 乔玉清 杨志明 

机构地区：[1]常州制药厂有限公司,江苏常州213018

出　　处：《广东化工》2016年第1期129-130,共2页Guangdong Chemical Industry

摘　　要：采用HPLC法测定富马酸替诺福韦二吡呋酯原料药的有关物质。方法：采用C18（150 mm×4.6 mm,5μm）色谱柱,流动相A为0.1%磷酸;使用乙腈作为流动相B相,采用梯度的洗脱方式进行洗脱;采用的流速为每分钟1 m L,采用260 nm的检测波长。结果：富马酸替诺福韦二吡呋酯及其已知杂质（杂质A、杂质B、杂质C、杂质D、杂质E、杂质F）的线性范围分别为0.5~12μg/m L;平均回收率分别为96.5%、97.2%、102.4%、95.6%、99.6%和94.8%;结论：本法简便、准确、可靠、适合于富马酸替诺福韦二吡呋酯原料药有关物质测定。To establish an HPLC method for quantitative determination of Tenofovir Disoproxil Fumarate. Methods： The analytical column was C18（150 mm×4.6 mm, 5 μm） column. The mobile phase was composed of Acetonitrile and water（with 0.1 % phosphoric acid） at a flow rate of 1ml/min. The wavelength of UV detector was 260 nm. Results： The linear ranges of Tenofovir Disoproxil Fumarate and the related substance were 0.5~12 μg/m L. The average recovery of Tenofovir Disoproxil Fumarate was 96.5 %、97.2 %、102.4 %、95.6 %、99.6 % and 94.8 %. Conclusion： This method is rapid, accurate and reliable to determine the content of Tenofovir Disoproxil Fumarate.

关 键 词：HPLC法 梯度洗脱 有关物质 测定 

分 类 号：R917[医药卫生—药物分析学]