冠心宁注射液中酚酸类成分的质量分析

通过高效液相色谱法同时测定冠心宁注射液中丹参素、原儿茶醛、迷迭香酸、紫草酸、丹酚酸B的含量.采用KromasilC18色谱柱(4.6mm×250mm,5μm),以乙腈-3%甲酸水溶液为流动相,流速1mL·min-1,柱温30℃,检测波长280nm.结果显示,丹参素、原儿茶醛、迷迭香酸、紫草酸、丹酚酸B分别在进样量0.00600~4.00,0.00615~4.10,0.00600~4.00,0.00606~4.04,0.00609~4.06μg与峰面积呈良好的线性关系,r分别为0.9993,0.9994,0.9993,0.9991,0.9992;回收率(n=6)分别为98.9%(RSD0.75%),98.1%(RSD1.2%),100%(RSD0.77%),98.7%(RSD1.7%),102%(RSD0.68%).按所建方法对13批样品中上述5种成分的含量进行测定.该方法简便、准确,重复性好,可用于冠心宁注射液中丹参素、原儿茶醛、迷迭香酸、紫草酸、丹酚酸B的质量控制.