胞磷胆碱钠片溶出度检测方法研究

Studies on dissolution test of Citicoline sodium tablets

目的建立高效液相色谱法测定胞磷胆碱钠片的溶出度。方法采用XB-C18色谱柱,以磷酸二氢钠溶液为流动相,流速1.0mL.min-1,检测波长为271nm,进样量20μL。结果胞磷胆碱钠在4.204μg.mL-1~37.84μg.mL-1的范围内其浓度与其峰面积呈良好的线性关系（r=1.000）,平均回收率为100.5%（RSD=1.1%,n=9）。结论高效液相色谱法测定胞磷胆碱钠片溶出度的方法既简便又准确,专属性强,改进了胞磷胆碱钠片原标准的溶出度测定方法。

OBJECTIVE To establish an HPLC method for the determination of citicoline sodium tablets dissolution.METHODS The analysis was carried out with XB-C18 column,using sodium dihydrogen phosphate solution as the mobile phase,the flow rate was l.0mL·min-1,the detection wavelength was 271nm,the injection volume was 20μL.RESULTS The results of citicoline sodium in 4.204μg·mL-1～37.84μg·mL-1 within the scope of its concentration and peak area showed a good linear relationship（r=1.000）,the average recovery rate was 100.5%（RSD=1.1%,n=9）.CONCLUSION the high performance liquid chromatographic determination of citicoline sodium tablets dissolution quantity method is simple and accurate,strong specificity,improved the original standard method for testing the dissolution of citicoline sodium tablets.