HPLC法测定硫普罗宁肠溶胶囊的释放度

Determination of release of Tiopronin enterin-coated capsules with HPLC

目的建立硫普罗宁肠溶胶囊释放度的HPLC测定方法。方法采用Phenomenex C18色谱柱，以0．4％磷酸-乙腈（93：7）为流动相，流速1．0ml·min^-1，检测波长220nm。结果硫普罗宁在20-300μg·mL^-1浓度范围内线性关系良好，相关系数r=0．9999，平均回收率为99．6％（n=9），BSD=0．6％。结论本方法准确、方便，可作为硫普罗宁肠溶胶囊释放度的测定方法。

OBJECTIVE To develop a HPLC method for the determination of release of Tiopronin Enteric-coated Capsules. METHODS A phenomenex ODS C18column was used with the mixture of 0. 1% phosphoric acid and aetonitrile （93： 7） as mobile phase, the flow rate as 1.0ml ： min ^- 1, the UV detector wavelength was 220nm, RESULTS The calibration curve was linear in the range of 20 - 300μ g · mL^-1, r = 0. 9999. The average recovery was 99.6% （ n = 9）, RSD = 0. 6%. CONCLUSION The propsoed HPLC method was convenient and accurate for the determination of release of Tiopronin Enterin-coated Capsules.