HPLC-ELSD法同时测定复方丹参缓释片中丹参酮Ⅱ_A和人参皂苷Rb_1含量

Determination of Tanshinone Ⅱ_A and Ginsenoside Rb_1 of compound Danshen sustained-release tablets by HPLC-ELSD

目的建立同时测定复方丹参缓释片中丹参酮ⅡA和人参皂苷Rb1含量的方法。方法采用高效液相色谱-蒸发光散射检测法。色谱柱为Agilent C18（250mm×4.6mm,5μm）,乙腈为流动相A,0.02%磷酸溶液为流动相B,梯度洗脱（0~5min,20%~25%流动相A;5~30min,25%~45%流动相A）,流速：1.0mL.min-1,蒸发光散射检测器,氮气流量1.6L.min-1,漂移管温度70℃。结果丹参酮ⅡA和人参皂苷Rb1分别在7.295~116.7μg.mL-1和4.063~65.00μg.mL-1的范围内呈良好线性关系,平均回收率分别为96.70%和98.92%,RSD分别为1.46%和0.93%。结论该方法操作简单、快速、准确,重复性好,可用于复方丹参缓释片的质量控制。

OBJECTIVE To determine the content of Tanshinone ⅡA and Ginsenoside Rb1 of compound Danshen sustained-release tablets by HPLC-ELSD.METHODS The column was Agilent C18,with acetonitrile as mobile phase A,0.02% phosphoric acid as mobile phase B,gradient elution（0～5min,20%～25% mobile phase A;5～30min,25%～45% mobile phase A）,The flow rate was 1.0L·min-1;ELSD detector was adopted,nitrogen flow rate was 1.6L·min-1,drift tube temperature was 70℃.RESULTS Tanshinone ⅡA and ginsenoside Rb1 at 7.295～116.7μg·mL-1 and 4.063～65.00μg·mL-1 range was linear,the average recoveries were 96.70% and 98.92%,RSD were 1.46% and 0.93%.CONCLUSION This method is simple,rapid,accurate,reproducible,and can be used for quality control of compound Danshen tablets.