目的建立健胃止痛五味胶囊中没食子酸的高效液相测定方法。方法采用Kromosil ODS C18(5μm,4.6×200 mm)色谱柱,以甲醇-水-N、N二甲基甲酰胺-冰醋酸(1.5:93:3.5:2)为流动相,检测波长262 nm。结果没食子酸在0.105μg~0.700μg之间具有良好的线性关系,平均回收率为97.64%、(RSD=1.1 6%n=5)。结论该方法准确度高,重现性良好,可作为健胃止痛五味胶囊中没食子酸的含量测定方法及用于控制药品质量。 Objective To establish a HPLC method for the determination of gallic acid in Jianweizhitong Wuwei Capsules. Methods A Kromosil ODS C18 (5 μm, 4.6×200 mm) column was used with methanol-water-N,N-dimethylformamide-glacial acetic acid (1.5:93:3.5:2) as the mobile phase and the detection wavelength was 262 nm. Results There was a good linear relationship between 0.105μg and 0.700μg gallic acid. The average recovery was 97.64% (RSD=1.16% n=5). Conclusion The method has high accuracy and good reproducibility. It can be used as a method for the determination of gallic acid in Jianwei Zhitong Wuwei Capsules and for the control of drug quality.