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目的采用HPLC测定复方益母口服液中盐酸水苏碱的含量,并与TLC法比较。方法采用Kromasil C18(250mm×4.6mm,5μm)色谱柱,流动相为乙腈-0.05mol·L-1磷酸二氢钾溶液(18∶82,pH5.5),流速1.0mL·min-1,柱温35℃,检测波长215nm,以外标法计算含量。结果盐酸水苏碱1.05～26.25μg与峰面积具良好的线性关系(r=0.9997),平均加样回收率为98.3%(n=9),RSD=1.17%。结论所用方法简便、准确、重复性好,可替代TLC法控制该制剂的质量。
Objective To determine the content of stachydrine hydrochloride in Fufang Yimu Oral Liquid by HPLC and compare with TLC method. Methods Kromasil C18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase was acetonitrile-0.05 mol·L-1 potassium dihydrogen phosphate solution (18:82, pH 5.5) Temperature 35 ℃, detection wavelength 215nm, calculated by external standard content. Results There was a good linear relationship between peak area and stained area (r = 0.9997). The average recovery was 98.3% (n = 9) and RSD was 1.17%. Conclusion The method is simple, accurate and reproducible. It can replace the TLC method to control the quality of the preparation.