HPLC同时测定双丹胶囊中7种主要成分

Simultaneous HPLC Determination of Seven Main Components of Shuangdan Capsules

目的:建立同时测定双丹胶囊中丹参素、原儿茶醛、芍药苷、迷迭香酸、紫草酸、丹酚酸B、丹皮酚7种有效成分的高效液相色谱分析方法。方法:采用Agilent Zorbax SB-C18色谱柱(4.6 mm×250 mm,5μm),流动相乙腈-0.1%甲酸溶液梯度洗脱,检测波长235 nm,流速1.0 m L·min^(-1),柱温30℃。结果:7种成分的线性范围分别为54.43~544.3,0.96~9.6,2.68~26.8,0.92~9.2,2.16~21.6,9.36~93.6,9.16~91.6 mg·L^(-1),r分别为0.999 7,0.999 6,0.999 5,0.999 3,0.999 2,0.999 7,0.9995。平均加样回收率分别为98.6%(RSD 1.8%),100.2%(RSD 1.9%),100.4%(RSD 2.0%),99.1%(RSD 2.5%),98.8%(RSD 2.3%),100.6%(RSD 1.9%),99.1%(RSD 1.8%)。结论:该分析方法准确可靠,重复性好,能更好地控制双丹胶囊的质量提供科学依据。

Objective： To establish a HPLC method for the simultaneous determination of tanshinol,protocatechuic aldehyde,paeoniflorin,rosmarinic acid,lithospermic acid,salvianolic acid B,and paeonol in Shuangdan capsules. Method： An Agilent Zorbax SB-C18 analytical column（ 4. 6 mm × 250 mm,5 μm） was used,with the mobile phase of acetonitrile-0. 1% formic acid solution for gradient elution at the detection wavelength of 235 nm,the flow rate was 1. 0 m L·min^-1,and the column temperature was 30 ℃. Result： The linear range of the seven components were 54. 43-544. 3,0. 96-9. 6,2. 68-26. 8,0. 92-9. 2,2. 16-21. 6,9. 36-93. 6,9. 16-91. 6 mg·L^-1respectively,and the correlation coefficients were 0. 999 7,0. 999 6,0. 999 5,0. 999 3,0. 999 2,0. 999 7,0. 999 5. The average recoveries were 98. 6%（ RSD 1. 8%）,100. 2%（ RSD 1. 9%）,100. 4%（ RSD 2. 0%）,99. 1%（ RSD 2. 5%）,98. 8%（ RSD 2. 3%）,100. 6%（ RSD 1. 9%）,99. 1%（ RSD1. 8%）. Conclusion： This analysis method is accurate,reliable and highly reproducible,and can provide a scientific basis for controlling the quality of Shuangdan capsules.