HPLC法同时测定复方丹参滴丸中7个活性成分的含量

Simultaneous Determination of Seven Active Ingredients in Compound Danshen Dropping Pills by HPLC

目的:建立同时分析测定复方丹参滴丸中7种活性成分(丹参素钠、原儿茶醛、丹酚酸B、三七皂苷R_1、人参皂苷Rg_1、人参皂苷Re、人参皂苷Rb_1)的方法。方法:色谱柱为安捷伦Poroshell 120 SB-C_(18)(100mm×3.0 mm,2.7μm),以乙腈为流动相A,0.05%磷酸溶液为流动相B,梯度洗脱,流速:1.0 ml·min^(-1);检测波长分别为280,210 nm。结果:丹参素钠、原儿茶醛、丹酚酸B、三七皂苷R_1、人参皂苷Rg_1、人参皂苷Re、人参皂苷Rb_1的线性范围分别为0.020～0.408μg(r=0.999 9),0.020～0.401μg(r=0.999 8),0.021～0.415μg(r=0.999 9),0.004～0.080μg(r=0.999 9),0.004～0.080μg(r=0.999 9),0.004～0.080μg(r=0.999 9),0.004～0.080μg(r=0.999 8);平均加样回收率97.1%～102.4%,RSD<1.7%(n=9)。结论:该方法操作简单,重复性好,为评价和监控复方丹参滴丸的质量提供可靠的方法。

Objective：To establish a method for the simultaneous determination of seven active ingredients（sodium salvianic A, protocatechualdehyde,salvianic acid B,notoginsenoside R_1,ginsenoside Rg,,ginsenoside Re and ginsenoside Rb_1 ） in compound Danshen dropping pills.Method：The determination was carried out with an Agilent Poroshell 120 SB-C_（18）（100 mm×3.0 mm, 2.7μm） column.The mobile phase consisted of acetonitrile（A）-0.05%phosphoric acid solution（B） with gradient elution at a flow rate of 1.0 ml·min^（-1）.The detection wavelengths were 280 nm and 210 nm.Result：The calibration curves were linear within the range of 0.020-0.408μg for sodium salvianic A（r = 0.999 9 ）,0.020-0.401μg for protocatechualdehyde（r = 0.999 8 ）,0.021-0.415μg for salvianic acid B（r = 0.999 9）,0.004-0.080μg for notoginsenoside R_1（r = 0.999 9）,0.004-0.080μg for ginsenoside Rg_1（r = 0.999 9）,0.004-0.080μg for ginsenoside Re（r= 0.9999） and 0.004-0.080μg for ginsenoside Rb_1（r = 0.999 8）.The average recoveries were within the range of 97.1%-102-4%with RSD of less than 1.7%（n=9）.Conclusion：The method is simple and repeatable,which can be applied in the quality control of compound Danshen dropping pills.