HPLC法测定他克莫司滴丸的含量

Determination of tacrolmius in tacrolmius dropping pills by HPLC

目的建立他克莫司滴丸的含量测定方法。方法采用高效液相色谱法,色谱柱为Hypersil ODS(4.0mm×250mm,5μm),流动相为乙腈-水(60:40),柱温为50℃,流速1.0mL.min-1,检测波长为220nm;对3批他克莫司滴丸进行含量测定。结果他克莫司浓度在100～800μg.mL-1范围内,峰面积与浓度线性关系良好,平均回收率分别为99.92%(n=9),RSD为0.69%,3批样品中他克莫司的含量分别为99.76%、99.79%、99.93%。结论本法测定他克莫司的含量,简便快捷、结果准确、重现性好、易于操作,可用于他克莫司滴丸中他克莫司含量的测定。

Objective To establish HPLC method for determination of tacrolimus in tacrolimus dropping pills.Methods HPLC method was performed on Hypersil ODS（4.0mm×250mm,5μm）,with acetonitrile-water（60：40） as mobile phase,the column temperature was 50℃,the flow rate was 1.0mL？min-1,and the UV detection wavelength was set at 220 nm.3 batch of samples were detected.Results Tacrolimus content has a linear range of 100~800μg？mL-1with a mean recovery of 99.92%（n=9,RSD=0.69%）.Conclusion The method appeared to be simple,rapid,accurate and repeatable and easy to operate,it could be used for determination of tacrolimus in tacrolimus dropping pills.