注射用丹参多酚酸UPLC的指纹图谱与组分分析

UPLC fingerprint and qualitative analysis on salvianolic acid for injection

目的建立注射用丹参多酚酸的UPLC指纹图谱分析方法,并结合Q-TOF-MS法及IT-TOFMS法对其化学成分进行定性分析。方法采用水(含体积分数0.2%甲酸)-乙腈(含体积分数2%甲醇)为流动相,梯度洗脱,采用Agilent ZORBAX Eclipse Plus C_(18)(150 mm×2.1 mm,1.8μm)色谱柱,同时采用LC-Q-TOF-MS法提供的化合物准确相对分子质量和LC-Q-TOF-MS法分析获得的化合物多级质谱信息对注射用丹参多酚酸进行成分分析。建立了注射用丹参多酚酸的UPLC指纹图谱集与共有模式,并以夹角余弦与相关系数对21批注射用丹参多酚酸样品进行相似度评级。结果鉴定酚酸类化合物23个;21批样品的相似度均大于0.960,确立了指纹图谱共有模式中的23个特征吸收峰。结论本方法可用于注射用丹参多酚酸的质量控制。

Objective To establish an UPLC method for fingerprint analysis of salvianolic acid for injection （SAFI）, and qualitatively analyze its constituents by Q-TOF-MS and IT-TOF-MS. Methods UPLC separation was performed on an Agilent ZORBAX Eclipse Plus C18 column（ 150 mm × 2. 1 mm, 1.8 μm）by gradient elution in 60 min with 0.2% formic acid-acetonitrile （ 2% methanol） as mobile phase. To analyze the constituents according to the relative molecule weight by LC-Q-TOF-MS and multistage MS informatics by LC-Q-TOF-MS, and the digital quantitative UPLC fingerprint of SAFI was established. The methods of included angel cosine and the correlation coefficient were used to assess the quality levels of twenty-one batches of SAFI. Results Twenty-three compounds of them were identified. The similarities of 21 batches of SAFI were all over 0. 960, and 23 characteristic peaks of UPLC fingerprint for SAFI were established. Conclusions The UPLC fingerprint of SAFI is established, the convenient and high specific method could be used to identify and evaluate the quality of SAFI.