高效液相色谱法测定螺内酯片的含量

Determination the Content of Spironolactone Tablets by HPLC

目的 建立螺内酯片剂中含量和降解产物的高效液相色谱法。方法 以DiamonsilTM(钻石 )C18(5 μm ,15 0× 4 .6mm)色谱柱为固定相 ,以 0 .0 2mol·L-1磷酸氢二铵 -乙腈 (4 5∶5 5 )为流动相 ,流速为 1.0ml/min ,检测波长为 2 5 4nm。结果 螺内酯与其他杂质峰可完全分开 ,螺内酯在浓度 5 0 .4～ 2 5 2 .0 μg·ml-1范围内与色谱峰峰面积呈良好线性关系 ,相关系数为 0 .9999,平均加样回收率为 99.7% ,RSD =1.3% (n =9)。结论 此方法操作简便、快速、重现性好 ,可有效地控制其产品质量。

Aim To develop a method for determination the content of spironolactone tablets and its decomposed substances by HPLC.Methods C 18 column as the stationary phase and 0.02mol·L -1 diammonium hydrogen phosphate-acetonitrile(45∶55) as the mobile phase were adopted.The detection was performed at 254nm.Results The standard curve was linear in the range of 50.4～252.0μg·ml -1 with the excellent correlation coefficient of 0.999 9.The average added recovery was 99.7%,RSD=1.3%.Conclusion The method is rapid, simple and accurate.