葡醛内酯片质量标准的研究

Study of quality and qualitative specification of Goucurolactone tablets

目的改进葡醛内酯片的鉴别反应,建立有效地葡醛内酯片定性定量检测方法。方法采用排除法分析葡醛内酯片鉴别反应的影响因素;采用以对羟基苯甲酸乙酯为内标的HPLC法进行含量测定,色谱柱:CLC-ODS(6.0mm×150mm,5μm),甲醇-水(65∶35)为流动相,流速1.0mL.m in-1,检测波长221nm,柱温40℃。结果改进的鉴别法重现性好,实验结果容易判断,避免了结论误判;葡醛内酯在0.5025~6.030mg.mL-1范围内线性关系良好,r=0.9999,平均回收率为99.8%,RSD为0.44%。结论本法准确、可靠地进行定性定量检测,能有效控制葡醛内酯片质量。

OBJECTIVE To establish qualitative and quantitative methods for the quality control of goucurolactone tablets.METHODS Goucurolactone in the tablets were identified by the improvement,and the content was determined by HPLC with Ethyl p-hydroxy benzoate for the internal standard.A CLC-ODS(6.0mm×150mm,5μm)column was used with mobile phase of CH_(3)OH-H_(2)O(65∶35) and flow rate of 1.0mL·min^(-1).The detection wavelength was set at 221nm and the column temperature at 40℃. RESULTS The improve identify and determination were accurate.Goucurolactone showed a good linear relationship at a range of 0.5025~6.030mg·mL^(-1)(r=0.9999).The average recovery was 99.8% and RSD was 0.44%.CONCLUSION The method is simple,specific and accurate.They can be used for qualitative control of the tablets.