高效液相色谱法测定甲磺酸伊马替尼的含量和有关物质  

Determination of Content and Related Substances of Imatinib Mesylate by HPLC

作　　者：刘娥[1] 

机构地区：[1]荆楚理工学院化工与药学院,湖北荆门448000

出　　处：《化学与生物工程》2013年第9期75-77,共3页Chemistry & Bioengineering

基　　金：荆楚理工学院项目(ZR201007)

摘　　要：采用HPLC法测定了原料药中甲磺酸伊马替尼含量和有关物质。色谱条件为：Diamonsil C18色谱柱（4．6mm×l50mm，5μm），柱温30℃，流动相：辛烷磺酸钠和磷酸二氢钾的缓冲溶液（pH值3．0）：甲醇。45：55（体积比），流速1．0mL·min^-1，检测波长285nm。结果表明．甲磺酸伊马替尼浓度在2．5～12．5μg·mL^-1范围内与峰面积线性关系良好，平均加样回收率为99．85％（n=6）。该方法操作简便、快速、灵敏、准确，样品处理容易，可用于甲磺酸伊马替尼的含量和有关物质的检测。A HPLC method for determination of content and related substances of imatinib mesylate was established. The HPLC system was conducted as follows： Diamonsil C18 column（4.6mm×l50mm,5μm）, mobile phase consisting of sodium octane sulphonic acid in aqueous KH2PO4 （pH= 3.0） ： MeOH in the volume ratio of 45 ： 55,the flow rate was 1.0 mL·min^-1 ,the column temperature was 30 ℃ ,the injection volume was 10 μL and the detector wavelength was 285 nm. The calibration curve for imatinib mesylate was linear in the range of 2.5～12.5μg·mL^-1. The average of recovery rate was 99.85% （n=6）. The method was rapid,simple,accurate,sensitive and suitable for determination of content and related substances of imatinib mesylate.

关 键 词：HPLC 甲磺酸伊马替尼 有关物质 含量 测定 

分 类 号：O657.72[理学—分析化学]