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

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,5 μm)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0.352~7.032 μg(r=0.9999),0.080~1.594 μg(r=0.9999),0.016~0.322 μg(r=0.9999),0.057~1.133 μg(r=0.9999),0.122~2.446 μg(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% trifluoroacetic 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,salvianolic 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),0.016-0.322 μg(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,accurate with high repeatability and stability,which is helpful to control the quality of Guanxinning injection.

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