高效液相色谱法测定克淋通分散片中没食子酸含量的方法学研究

Determination of Gallic Acid in Kelintong Dispersible Tablet by HPLC

目的建立克淋通分散片中没食子酸的含量测定方法。方法采用高效液相色谱法。色谱柱为安捷伦Zob-ax SB-C18(150mm×4.6mm,5μm);甲醇-水-N,N-二甲基甲酰胺-冰醋酸(1∶92∶4∶3)为流动相,流速为0.5m l/m in,检测波长为272nm。结果本法线性关系良好,平均加样回收率为102.18%,RSD为2.69%。结论本法操作简便,分离效果好,可用于克淋通分散片质量控制。

Objective： To establish the determination method of gallic acid in Kelintong Dispersible Tablet. Method： HPLC with Agilent Zobax SB - C18 （ 150mm × 4. 6mm, 5 μm） column was used. Methanol - water - dimethylformamide - ace - tic acid glacial （ 1 ： 92 ： 4 ： 3） was used as mobile phase. The flow rate was 0. 5ml/min. The detection wavelength was at 272nm. Results： The linearity of this method was good. The recovery of the added sample was 102. 18% , RSD was 2.69%. Conclusion： This method is convenient with a good separating degree and can be used for the quality control of Kelintong Dispersible Tablet.