甲磺酸伊马替尼片溶出度检测方法的建立  

Establishment of dissolution tests for imatinib mesylate tablets

作　　者：盛宝东 王雪琦[1] 汪电雷[1,2] 汪珊珊[1] 王淑君[1] 陈亚军[1] 李洁[1] 彭兆亮[1] 樊玲[1] 

机构地区：[1]安徽中医药大学药学院,安徽合肥230012 [2]安徽中医药大学药物代谢动力学研究室,安徽合肥230012

出　　处：《安徽医药》2015年第6期1078-1081,共4页Anhui Medical and Pharmaceutical Journal

基　　金：安徽省科技攻关计划项目(No 13010420097)

摘　　要：目的：建立甲磺酸伊马替尼片溶出度测定方法。方法以0．1 moL·L^－1盐酸溶液为溶出介质，桨法，转速50 r·min^－1，采用紫外分光光度法在波长264 nm处测定吸光度并计算溶出度。结果甲磺酸伊马替在2．22～15．54 mg·L^－1浓度范围内线性关系良好，A＝0．0519C＋0．0036（r＝0．9999，n＝7）；平均回收率100．04％；样品溶出度批内及批间均一性良好。结论该方法快速简便，能用于甲磺酸伊马替尼片的溶出度测定。Objective To establish a method for determining the dissolution of imatinib mesylate tablets.Methods The paddle method was adopted with 0.1 moL·L-1 hydrochloric acid solution as dissolution medium at rotation speed of 50 r·min-1 .The content deter-mination was conducted by UV spectrophotometry with detection wavelength of 264 nm and calculate the dissolution.Results The stand curve of imatinib mesylate as a good linear relationship with the range of 2.22～15.54 mg·L-1.Linear equation is：A =0.051 9C＋0.003 6（r=0.999 9,n=7）.The average recovery was 100.04%.The samples dissolution having a good homogeneity both the inter-assay and within-batch.Conclusion The method is quick and convenient and can be used for detection of dissolution of the imatinib mesylate tablets.

关 键 词：甲磺酸伊马替尼片 溶出度 紫外-可见分光光度法 

分 类 号：R927[医药卫生—药学]