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建立同时测定注射用丹参(冻干)中丹参素钠、原儿茶酸、原儿茶醛、异阿魏酸、丹酚酸G和迷迭香酸6种酚酸类成分含量的UPLC法。采用ACQUITY UPLCHSS T3(2.1 mm×100 mm,1.8μm)色谱柱,流动相为0.1%甲酸(A)-乙腈(B)系统梯度洗脱(0 min,100%A;0~5 min,0%B~8%B;5~10 min,8%B~20 B;10~20 min,20%B~45%B;20~24 min,45%B~100%B;24~25 min,100%B~100%A;25~30 min,100%A),流速0.3 mL/min,柱温30℃,检测波长254 nm。结果显示6种酚酸类成分在一定范围内(丹参素钠101.5~1624.0μg/mL、原儿茶酸0.846~13.540μg/mL、原儿茶醛82.60~1321.60μg/mL、异阿魏酸5.01~80.16μg/mL、丹酚酸G 8.97~143.52μg/mL、迷迭香酸8.67~138.72μg/mL)线性关系良好(r=0.9990~0.9998),平均加样回收率在95.1%~102.9%范围内,RSD均小于3.0%。该法经验证准确可靠,可用于该制剂中6种酚酸的含量测定,为其多成分质量控制提供了科学依据。
To establish a UPLC method for simultaneous determination of six kinds of phenolic acids such as Danshensu Sodium, Protocatechuic acid, Protocatechuic aldehyde, Isoferulic acid, Salvianolic acid G and Rosmarinic acid in Radix Salviae Miltiorrhizae (lyophilized). The mobile phase consisted of 0.1% formic acid (A) -acetonitrile (B) system with gradient elution (0 min, 100% A; 0-5 min, 0% B to 8% B; 5 to 10 min, 8% B to 20 B; 10 to 20 min, 20% B to 45% B; 20 to 24 min, 45% B to 100% B; , 100% B to 100% A; 25 to 30 min, 100% A) at a flow rate of 0.3 mL / min and a column temperature of 30 ° C with a detection wavelength of 254 nm. The results showed that the content of six kinds of phenolic acids in a certain range (sodium danshensu 101.5 ~ 1624.0μg / mL, protocatechuic acid 0.846 ~ 13.540μg / mL, protocatechuic aldehyde 82.60 ~ 1321.60μg / mL, ~ 80.16μg / mL, Salvianolic acid 8.997 ~ 143.52μg / mL, rosmarinic acid 8.67 ~ 138.72μg / mL). The average recoveries ranged from 95.1% to 102.9% Within the range, RSD is less than 3.0%. The method is validated accurately and reliably, and can be used for the determination of six kinds of phenolic acids in the preparation, providing a scientific basis for the multi-component quality control.