HPLC法同时测定双丹颗粒中3种成分的含量

目的:建立同时测定双丹颗粒中丹酚酸B、丹参酮ⅡA、丹皮酚含量的方法。方法:采用高效液相色谱法。色谱柱为Pheonomenex C18(250 mm×4.6 mm,5μm),流动相为甲醇-乙腈-甲酸(甲酸8.3 ml→500 ml)水溶液(30∶7∶63,V/V/V),流速为1.0ml/min,检测波长为286 nm,柱温为30℃。结果:丹酚酸B、丹参酮ⅡA、丹皮酚的进样量分别在0.414⁴.140、0.0644.140、0.064⁰.640、0.2280.640、0.228².280μg范围内与各自峰面积积分值呈良好的线性关系(r分别为0.999 8、0.999 7、0.999 8);精密度、稳定性、重复性试验的RSD<3%;平均加样回收率分别为97.35%(RSD=1.19%,n=6)、97.56%(RSD=1.86%,n=6)、96.86%(RSD=1.67%,n=6)。结论:该方法简单、可靠、专属性强,可作为双丹颗粒的质量控制方法。

Content Determination of 3 Components in Shuangdan Particles by HPLC

OBJECTIVE： To establish the method for the content determination of salvianolic acid B, tanshinone ⅡA and paeonol in Shuangdan particles.METHODS： HPLC method was adopted. The determination was performed on Pheonomenex C18（250 mm×4.6 mm,5 μm） column with mobile phase consisted of methanol-acetonitrile-formic acid （8.3 ml→500 ml） solution （30：7：63, V/V/V） at the flow rate of 1.0 ml/min. The detection wavelength was set at 286 nm, and column temperature was 30 ℃. RESULTS： The linear ranges of salvianolic acid B, tanshinone Ⅱ A and paeonol were 0.414-4.140 μg（r=0.999 8）, 0.064-0.640 μg（r= 0.999 7）and 0.228-2.280 μg（r=0.999 8）. RSDs of precision, stability and reproducibility tests were all lower than 3%. The average recoveries were 97.35% （RSD=1.19% ,n=6）, 97.56% （RSD=1.86% ,n=6） and 96.86% （RSD=1.67% ,n=6）. CONCLUSIONS ： The method is simple, reliable and specific. It can be used for quality control of Shuangdan particles.