HPLC法测定甘草酸二铵胶囊含量及有关物质

Content Determination of Diammonium Glycyrrhizinate Capsule and Related Substances by HPLC

目的:建立测定甘草酸二铵胶囊含量及有关物质的方法。方法:采用高效液相色谱法。色谱柱为AgilentExtend-C18柱,流动相为乙腈-0.01mo·lL-1磷酸溶液(38∶62),检测波长为252nm,柱温为35℃,流速为1.0mL·min-1,进样量为20μL。结果:甘草酸二铵检测浓度在12.5～1250μg·mL-1范围内与峰面积积分值呈良好的线性关系;平均回收率为100.1%,RSD=0.3%(n=9)。结论:该法专属性强、灵敏度高,可用于甘草酸二铵胶囊的质量控制。

OBJECTIVE： To establish a method for the content determination of Diammonium glycyrrhizinate capsule and related substances. METHODS： HPLC method was adopted. The determination was performed on Agilent Extend-C18 column with mobile phase consisted of acetonitrile-0.01 mol·L-1 phosphate solution （38 ∶ 62） at flow rate of 1.0 mL·min-1. The determination wavelength was set at 252 nm and column temperature was 35 ℃. The injection volume was 20 μL. RESULTS： The linear range of diammonium glycyrrhizinate was 12.5～1 250 μg·mL-1 with an average recovery of 100.1% （RSD=0.3%, n=9）. CONCLUSION： The method is specific and sensitive, and it can be used for the quality control of Diammonium glycyrrhizinate casuple.