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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 7 effective components of Danshensu, protocatechuic aldehyde, paeoniflorin, rosmarinic acid, lithospermic acid, salvianolic acid B and paeonol in Shidan Capsules. METHODS: The mobile phase acetonitrile-0.1% formic acid was eluted with a Agilent Zorbax SB-C18 column (4.6 mm × 250 mm, 5 μm) with a detection wavelength of 235 nm and a flow rate of 1.0 mL · min -1 Temperature 30 ℃. Results: 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 -1, r were 0.999 7,0.999 6,0.999 5,0.999 3,0.999 2,0.999 7,0.9995. 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% (RSD 1.8%). Conclusion: The method is accurate and reliable, good repeatability, and can provide scientific basis for the quality control of Shuang Dan Capsule.