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出 处:《中国医药导报》2012年第13期110-111,共2页China Medical Herald
摘 要: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。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.
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