UPLC法同时测定注射用丹参(冻干)中6种酚酸的含量

Simultaneous determination of six phenolic acids in Danshen injection(lyophilized powder) by UPLC

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 UPLCHSS 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 phenolic acids including sodium danshensu, protocatechuic acid, protocatechuic aldehyde, isoferulic acid, salvianolic acid G and rosmaric acid in Danshen Injection （lyophilized powder）. The analysis was performed on an ACQUITY UPLC （C） HSS T3 column （ 2. 1 mm × 100 mm, 1.8 μm） with acetonitrile and 0. 1% formic acid solution as mobile phase at a flow rate of 0.3 mL/min in gradient elution. The detection wavelength was set at 254 nm. All six test components had good linearity （ r = 0. 9990 - 0. 9998 ） in the defined ranges （ sodium danshensu： 101.5 - 1624. 0 μg/mL, protocatechuic acid 0. 846 - 13.540 μg/mL, protocatechuic aldehyde 82. 60 - 1321.60μg/mL, isoferulic acid 5. 01 - 80. 16 μg/mL, salvianolic acid G 8.97- 143.52 μg/mL, rosmaric acid 8.67 - 138.72 μg/mL）. The average recovenes were between 95.1% - 102.9%, with RSDs below 3%. The established method was validated, and applicable to simultaneous determination of 6 phenolic acids of the injection. The method provides scientific bases for the quality control of multi-components.