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期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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UPLC法同时测定丹参片中11个水溶性和脂溶性成分的含量

Simultaneous determination of eleven water-soluble and lipophilic components in Danshen tablets by UPLC

作者(英文):
分类号:R917
出版年·卷·期(页码):2019,39 (4):652-661
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:采用UPLC法同时测定丹参片中11个水溶性和脂溶性成分丹参素钠、二氢丹参酮、隐丹参酮、丹参酮、丹参酮ⅡA、熊果酸、原儿茶醛、迷迭香酸、紫草酸、丹酚酸B和丹酚酸A的含量。方法:采用Waters ACQUITY UPLC C8色谱柱(2.1 mm×100 mm,1.7 μm),以0.1%磷酸水溶液(A)-乙腈(B)为流动相,梯度洗脱(0~13 min,5% B→22% B;13~16 min,22% B→40% B;16~20 min,40% B→53% B;20~39 min,53% B→80% B),流速0.3 mL·min-1;检测波长280 nm,柱温20℃,样品管理器温度4℃。结果:丹参素钠、二氢丹参酮、隐丹参酮、丹参酮、丹参酮ⅡA、熊果酸、原儿茶醛、迷迭香酸、紫草酸、丹酚酸B和丹酚酸A进样量分别在0.203 1~8.125、0.035 8~1.431、0.063 3~2.531、0.091 8~3.671、0.090 2~3.606、0.096 1~3.844、0.036 0~1.439、0.158 1~6.324、0.103 1~4.125、0.283 1~11.325和0.191 2~7.647 μg的范围内与色谱峰峰面积呈良好线性关系;平均回收率(n=6)分别为99.2%、99.7%、99.8%、98.9%、99.5%、99.4%、99.6%、99.5%、98.7%、99.3%和98.9%,RSD分别为0.49%、0.44%、0.19%、0.61%、0.63%、0.29%、0.79%、0.48%、0.92%、0.40%和0.88%。8个厂家74批丹参片样品中上述11个成分含量范围分别为0.645~7.182、0.079~1.281、0~2.21、0.109~3.37、0.203~3.063、2.033~3.527、0~1.063、1.354~5.677、1.046~3.909、32.759~51.588、0.156~9.472 mg·g-1结论:所建立的方法可作为丹参片的质量控制方法。

-----英文摘要:---------------------------------------------------------------------------------------

Objective:To establish an UPLC method for simultaneous determination of 11 water soluble and lipophilic components including danshensu sodium, dihydrotanshinone, cryptotanshinone, tanshinone, tanshinone ⅡA, ursolic acid, protocatechuic aldehyde, rosmarinic acid, lithospermic acid, salvianolic acid B and salvianolic acid A in Danshen tablets. Methods:The sepatation was performed on Waters ACQUITY UPLC C8 column (2.1 mm×100 mm, 1.7 μm) with the mobile phase consisting of 0.1% phosphoric acid aqueous (A) -acetonitrile (B) by gradient elution (0-13 min, 5%B→22%B;13-16 min, 22%B→40%B;16-20 min, 40%B→53%B;20-39 min, 53%B→80%B) at a flow rate of 0.3 mL·min-1. The column temperature was 20℃ and the sample manager temperature was 4℃. The detection wavelength was 280 nm. Results:The linear ranges of danshensu sodium, dihydrotanshinone, cryptotanshinone, tanshinone, tanshinone ⅡA, ursolic acid, protocatechuic aldehyde, rosmarinic acid, lithospermic acid, salvianolic acid B and salvianolic acid A were 0.203 1-8.125, 0.035 8-1.431, 0.063 3-2.531, 0.091 8-3.671, 0.090 2-3.606, 0.096 1-3.844, 0.036 0-1.439, 0.158 1-6.324, 0.103 1-4.125, 0.283 1-11.325 and 0.191 2-2.296 μg, respectively. The recoveries (n=6) of the above-mentioned components were 99.2%, 99.7%, 99.8%, 98.9%, 99.5%, 99.4%, 99.6%, 99.5%, 98.7%, 99.3% and 98.9%, respectively, and the relative standard deviations were 0.49%, 0.44%, 0.19%, 0.61%, 0.63%, 0.29%, 0.79%, 0.48%, 0.92%, 0.40% and 0.88%, respectively. The content ranges of above-mentioned component in 74 batches of samples from 8 manufactures were 0.645-7.182, 0.079-1.281, 0-2.21, 0.109-3.37, 0.203-3.063, 2.033-3.527, 0-1.063, 1.354-5.677, 1.046-3.909, 32.759-51.588 and 0.156-9.472 mg·g-1, respectively. Conclusion:The method can be used for quality control of Danshen tablets.

-----参考文献:---------------------------------------------------------------------------------------

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