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目的:建立HPLC法同时测定注射用冠心宁中原儿茶醛、阿魏酸、丹酚酸B含量的方法。方法:色谱柱:Kromasil C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.6%磷酸溶液梯度洗脱,检测波长:286 nm。结果:原儿茶醛在0.022～0.540μg(r=0.999 3)范围内与峰面积呈良好的线性关系,平均回收率为99.10%,RSD=1.45%;阿魏酸在0.022～0.550μg(r=0.999 7)范围内与峰面积呈良好的线性关系,平均回收率为99.89%,RSD=1.01%;丹酚酸B在0.206～2.506μg(r=1.000 0)范围内与峰面积呈良好线性关系,平均回收率为101.45%,RSD=1.32%。结论:该方法准确、重复性好,可用于注射用冠心宁的质量控制。
OBJECTIVE: To establish a HPLC method for simultaneous determination of Zhongyuan catechuol, ferulic acid and salvianolic acid B in injection. Methods: Kromasil C_ (18) column (250 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase consisted of gradient elution with acetonitrile-0.6% phosphoric acid solution. The detection wavelength was 286 nm. RESULTS: Protocatechuic aldehyde showed a good linear relationship with the peak area in the range of 0.022-0.540 μg (r = 0.999 3) with an average recovery of 99.10% and a RSD of 1.45%. Ferulic acid showed good linearity in the range of 0.022-0.550 μg = 0.999 7). The average recovery was 99.89% and the RSD was 1.01%. The concentration of salvianolic acid B in the range of 0.206 ~ 2.506μg (r = 1.000 0) showed a good linear relationship with the peak area Relationship, the average recovery was 101.45%, RSD = 1.32%. Conclusion: The method is accurate, reproducible and can be used for the quality control of Guanxinning injection.