咽立爽口含滴丸中甘草酸单铵盐的质量标准

Quality Standard of Glycyrrhizic Acid Ammonium Salt in Yanlishuang Kouhan Diwan

摘要:

目的：建立咽立爽口含滴丸的鉴别与含量测定方法。方法：采用TLC对甘草酸单铵盐进行定性鉴别；采用HPLC以羟基苯甲酸丁酯为内标物测定甘草酸单铵盐含量，流动相乙腈-0.01 mol·L^-1磷酸溶液（38：62），流速1.0 mL·min^-1，检测波长250 nm，柱温25 ℃。结果：该方法专属性好、准确，甘草酸单铵盐在0.212~3.71 mg具有良好线性关系（r=0.999 9），平均回收率为101.07%。结论：该法简便，快速，准确，可用于产品的质量控制。

Abstract:

Objective: The identification and determination method were established for Yanlishuang Kouhan Diwan. Method: The TLC method was used for identifying Glycyrrhizic acid ammonium salt;The HPLC method was used for determination of Glycyrrhizic acid ammonium salt in yanlishuang Kouhan Diwan, Butyl paraben as internal standard.Diamonsil C₁₈ column was adopted.The mobile phase was Acetonitrile-0.01 mol·L^-1 phosphoric acid (38:62) at a flow rate of 1.0 mL·min^-1.The detection wavelength was 250 nm and column temperture was 25 ℃. Result: This method is specfic and accurate to Glycyrrhizic acid ammonium salt in Yanlishang Kouhan Diwan.The linear range of Glycyrrhizic acid ammonium salt within 0.212-3.71 mg (r=0.999 9), The average recovery was 101.07%. Conclusion: The method is convenient, sensitive and accurate, which could be used for quality control of the drug.