RP-HPLC同时测定冠心宁注射液中丹参素、原儿茶醛、阿魏酸、迷迭香酸和丹酚酸B的含量

RP-HPLC simultaneous determination of danshensu,protocatechuic aldehyde,ferulic acid,rosmarinic acid,and salvianolic acid B in Guanxinning injection

目的:建立反相高效液相色谱法同时测定冠心宁注射液中丹参素、原儿茶醛、阿魏酸、迷迭香酸和丹酚酸B的含量。方法:采用Kromasil C18(4.6 mm×250 mm,5μm)色谱柱,流动相为乙腈(A)-0.05%三氟乙酸(B),梯度洗脱(0～65 min,2%A→30%A),流速0.8 mL.min-1,检测波长288 nm,柱温40℃。结果:丹参素、原儿茶醛、阿魏酸、迷迭香酸和丹酚酸B进样量分别在0.352～7.032μg(r=0.9999),0.080～1.594μg(r=0.9999),0.016～0.322μg(r=0.9999),0.057～1.133μg(r=0.9999),0.122～2.446μg(r=0.9999)范围内呈现良好的线性关系;平均回收率(n=6)分别为100.9%(RSD=1.5%),102.4%(RSD=0.9%),103.6%(RSD=0.9%),102.6%(RSD=2.0%),102.0%(RSD=2.1%);重复性试验,5个成分含量的RSD(n=6)均小于2.5%。结论:所建立的方法简便、准确,具有良好的重复性和稳定性,可用于冠心宁注射液的质量控制。

Objective： To develop an HPLC method for simultaneous determination of danshensu, protocatechuic aldehyde,ferulic acid, rosmarinic acid, salvianolic acid B in Guanxinning injection. Methods： Analysis was performed on a Kromasil C18 （4.6 mm ×250 mm,5 μm） analytical column with gradient elution（0 -65 min,2% A→30% A） of acetonitrile （A） - 0.05 % trifluoroaeetie acid （ B ） at the flow rate of 0.8 mL · min^-1 The detection wavelength was 288 nm, and the column temperature was maintained at 40 ℃. Results： Danshensu, protocatechuic aldehyde ,ferulic acid ,rosmarinic acid, salvianolie acid B had good linearity in the ranges of 0. 352 -7.032 μg（ r = 0. 9999） ,0. 080 - 1. 594 μg（ r = 0. 9999） ,0. 016 -0. 322μg （ r = 0. 9999 ） ,0. 057 - 1. 133 μg （r = 0. 9999 ）, 0. 122 - 2. 446 μg（ r = 0. 9999）, respectively; The average recoveries were 100. 9% （RSD = 1.5% ）, 102. 4% （RSD = 0. 9% ）, 103.6% （RSD = 0. 9% ）, 102. 6% （RSD = 2. 0% ）, 102. 0% （RSD = 2. 1% ）, respectively; Repeatability experiments showed that RSD values of their contents were less than 2. 5%. Conclusion： The method developed is simple, accu- rate with high repeatability and stability,which is helpful to control the quality of Guanxinning injection.