【摘要】 目的建立度他雄胺软胶囊制剂的含量测定新方法。方法采用高效液相色谱法,色谱柱采用Phenomenex Luna C18（4.6 mm×150 mm,3.0μm）,梯度洗脱,柱温:40℃,流速:1.0 m L·min^-1,进样量:50μL。紫外检测器检测波长采用240和285 nm双波长检测。结果主成分度他雄胺和抗氧剂二丁基羟基甲苯分别在9.785³6.693μg·m L^-1和0.679².545μg·m L^-1内线性关系良好,平均回收率分别为99.9%和102%,符合规定。结论该方法操作简便,专属性强,准确度高,可作为度他雄胺软胶囊含量测定的质量控制方法。更多还原

【Abstract】 OBJECTIVE To establish a high performance liquid chromatography method to determine the contents of dutasteride soft capsules.METHODS The chromatographic analysis was performed on a Phenomenex C18（Luna,4.6 mm × 150 mm,3.0 μm）column.The mobile phase was gradiently eluted.The flow rate was 1.0 m L·min^-1.The detection wavelength was set at 240 and 285 nm,and the injection volume was 50 μL.RESULTS The linear ranges of dutasteride and butylated hydroxy Toluene（BHT） were9.785-36.693 and 0.679-2.545 μg·m L^-1,and the recoveries of this method were 99.9% and 102% with RSDs of 0.9% and3.6%,respectively.CONCLUSION This assay is proved to be simple,specific,and accurate.It can be effectively applied in the quality control of dutasteride soft capsules.更多还原