复方坦索罗辛非那雄胺胶囊的含量测定方法研究

目的探讨复方坦索罗辛非那雄胺胶囊的制备和质量控制。方法将非那雄胺和微晶纤维素混合后与溶解有坦索罗辛的乙醇溶液混合制粒装入胶囊中。盐酸坦索罗辛的含量测定采用高效液相色谱法,色谱柱为KromasilC18柱(250mm×4.6mm,5μm),流动相为乙腈-0.2mol.L-1磷酸二氢钾-0.2mol.L-1磷酸盐溶液=5:7:7(v/v),流速为1mL.min-1,柱温为30℃,检测波长225nm。非那雄胺的含量测定也采用高效液相色谱法,色谱柱为WatersC18柱(250mm×4.6mm,5.0μm),流动相为甲醇-水(75:25),流速为1mL.min-1,检测波长220nm。结果结论所用方法简单,易于操作,含量测定方法简便、准确、回收率高,可用于复方坦索罗辛非那雄胺胶囊的质量控制。

Study on content determination of compound tamsulosin hydrochloride and finasteride capsules

Objective To research a method for content determination of compound tamsulosin hydrochloride and finasteride capsules.Methods finasteride and microcrystalline cellulose mixed with dissolved tamsulosin ethanol solution mixed granulation encapsulated.HPLC was used for the content determination of tamsulosin hydrochloride.The chromatographic procedure was carried out using Kromasil C18 column(250mm×4.6mm,5μm) as the analytic column with acetonitrile-0.2mol·L-1 potassium dihydrogen phosphate-0.2 mol·L-1 phosphoric acid=(5:7:7,v/v) as the mobile phase,flow rate was 1 mL·min-1,the column temperature was 30℃.The detection wavelength was at 225nm.HPLC was used for the content determination of Finasteride.A Waters C18 column(250mm×4.6mm,5 μm) was used with the mixture of MeOH and H2O=(75:25,v/v) as the mobile phase.The flow rate of 1mL·min-1.The detection wavelength was at 220nm.Results and conclusion This preparation method is simple and easy to be operated.The content determination method is accurate and simple with high recovery rate,which can be used for the quality control of compound tamsulosin hydrochloride and finasteride capsules.