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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 a method for UPLC fingerprinting of Salviae miltiorrhizae polyphenols for injection, and analyze its chemical composition by Q-TOF-MS and IT-TOFMS. Methods The mobile phase consisted of water (containing 0.2% formic acid by volume) and acetonitrile (containing 2% methanol) as the mobile phase. The mobile phase consisted of an Agilent ZORBAX Eclipse Plus C18 (150 mm × 2.1 mm, 1.8 μm) At the same time, the composition of salvia miltiorrhiza polyphenols for injection was analyzed by using the accurate relative molecular mass of compound provided by LC-Q-TOF-MS and the multi-level mass spectral information of compound obtained by LC-Q-TOF-MS. UPLC fingerprinting and consensus model of salvia miltiorrhiza polyphenols for injection were established. Similarity ratings of Salvia miltiorrhiza polyphenols samples for injection of 21 batches were scored by included cosine and correlation coefficient. Results 23 phenolic compounds were identified. The similarity of 21 batches of samples was greater than 0.960, and 23 characteristic absorption peaks in the common pattern of fingerprint were established. Conclusion This method can be used for quality control of Salvia miltiorrhiza polyphenols for injection.