RP-HPLC法测定消痔灵片中没食子酸的含量

目的建立消痔灵片有效成分含量测定的方法,为其质量标准的制订提供依据。方法采用RP-HPLC法测定,以没食子酸为对照品,色谱柱：Sino Chrom ODS-APC18（250 mm×4.6 mm,5μm）,流动相：甲醇-水-磷酸（6∶94∶0.2）,检测波长：266 nm,流速：1.0 mL/min,柱温：（25±1）℃。结果没食子酸在18~48μg/mL范围内呈良好的线性关系（r=0.999 1）,平均回收率为99.75%,RSD=0.97%。结论本方法准确,简便,灵敏度高,可用于消痔灵片中没食子酸的含量测定并有效评价该制剂的质量。

Determination of Gallic acid in Xiaozhiling Tablet by RP-HPLC

Objective To establish a method for determining the active principlein the Xiaozhiling Tablet,and provide a standard for the quality.Methods A RP-HPLC method was set up to determine the content of Gallic acid in Xiaozhiling Tablet,which was used Sino Chrom C18(4.6 mm×250 mm,5 μm) column,and methanol-water-Phosphoric acid(6∶94∶0.2) as the mobile phase,the UV detection wavelength was 266 nm,with a flow rate of 1.0 mL/min at(25 ±1)℃.Results A good linear was obtained in the range of 18~48 μg/mL,and the average recovery was 99.75%,RSD was 0.97%.Conclusion The method is simple,rapid,accurate,and with good reproducibility for the determination of Gallic acid in Xiaozhiling Tablet.