高效液相色谱法测定脉络宁注射液中哈巴俄苷的含量

Content Determination of Harpagoside in Mailuoning Injections by HPLC

目的:建立高效液相色谱法测定脉络宁注射液中哈巴俄苷的含量。方法:色谱柱为Diamonsil C18柱(150 mm×4.6 mm,5μm);流动相A为0.03%的磷酸水溶液,流动相B为乙腈;流速为1 ml/min;柱温为30℃;检测波长为278 nm;单次自动进样体积为5μl。结果:哈巴俄苷质量浓度在5.0~500.0μg/ml(即0.025~2.500 mg)范围内与峰面积呈良好的线性关系(r2=0.999 7),平均回收率为98.11%(RSD=1.32%,n=5)。结论:本方法为脉络宁注射液质量标准的制定提供了新的依据,为临床安全用药提供了理论指导。

Objective：To establish the method for content determination of harpagoside in mailuoning injections by HPLC.METHODS： The chromatographic column was Diamonsil C18 column（150 mm×4.6 mm,5 μm）,the mobile phase A was 0.03%phosphoric acid solution,and mobile phase B was acetonitrile,with flow rate of 1 ml/min,column temperature of 30 ℃,detection wavelength of 278 nm,and single automatic sample volume of 5 μl.RESULTS： The harpagoside showed a good linear relationship in content of 5.0 μg/ml-500.0 μg/ml（0.025 mg-2.500 mg）（r2=0.999 7）,the average recovery was 98.11%（RSD=1.32%,n=5）.CONCLUSIONS： This method provides new reference for the formulation of quality standard of mailuoning injections,in addition of theoretical guidance for clinical safety administration.