HPLC法同时测定心宁片中3个有效成分的含量

Simultaneous Determination of Three Effective Components in Xinning Tablets by HPLC

目的:建立HPLC法同时测定心宁片中芦丁、丹酚酸B、人参皂苷Rb1含量的方法。方法:采用CAPCELL PAK MG(250 mm×4.6 mm,5μm)色谱柱,流动相为乙腈(A)-0.1%磷酸溶液(B),梯度洗脱,流速1.0 ml·min^(-1),柱温35℃,检测波长为354 nm、286 nm和203 nm(波长切换方式)。结果:芦丁浓度在0.027 3~1.360 0 mg·ml^(-1)范围内(r=1.000 0),丹酚酸B浓度在0.024 4~1.220 0 mg·ml^(-1)范围内(r=1.000 0),人参皂苷Rb_1浓度在0.018 6~0.931 0 mg·ml^(-1)范围内(r=0.999 9),与峰面积均呈良好的线性关系;平均回收率分别为102.3%,98.7%,101.7%,RSD分别为1.1.%,0.8%,1.8%(n=6)。结论:本文建立HPLC法可实现同时测定芦丁、丹酚酸B、人参皂苷Rb13种有效成分,方法快速、简便、结果准确,可为心宁片提供更全面、可靠的质量控制方法。

Objective： To establish an HPLC method for the simultaneous determination of rutin, salvianolic acid B and ginsenoside Rbl in Xinning tablets. Methods： The samples were separated on a CAPCELL PAK MG（250 mm×4.6 mm,5μm）column with gradient elution using acetonitrile（A） and 0.1% phosphoric acid（B） as the mobile phase at a flow rate of 1.0 ml·min^-1. The column temperature was set at 35℃. The wavelengths were set on 354nm, 286nm and 203 nm （in a wavelength switching mode）. Resulls ： The linear range of rutin was 0. 027 3-1. 3600 mg·ml^-1 （ r = 1. 000 0）, that of salvianolic acid B was 0.024 4-1. 220 0 mg·ml^-1 （ r = 1. 000 0） , and that of ginsenoside Rb, was 0.018 6-0.931 0 mg ~ ml -l （ r = 0. 999 9 ） , and the average recovery （ n = 6 ） was 102.3% （RSD = 1.1% ） ,98.7% （RSD =0.8% ） and 101.7% （RSD = 1.8% ） （n =6）, respectively. Conclusion： A rapid, simple, accurate HPLC method is successfully established for the simultaneous determination of 3 effective components in Xinning tablets, which is helpful to the quality control of Xinning tablets.