中国中药杂志

2016, v.41(16) 3022-3026

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HPLC-DAD-QTOF-MS联用技术研究大株红景天胶囊指纹图谱
Fingerprint of Dazhu Hongjingtian capsule by HPLC-DAD-QTOF-MS

刘光大;黄文哲;马世平;王振中;
LIU Guang-da;HUANG Wen-zhe;MA Shi-ping;WANG Zhen-zhong;Jiangsu Kanion Pharmaceutical Co.,Ltd.;China Pharmaceutical University;

摘要(Abstract):

建立了大株红景天胶囊HPLC-DAD指纹图谱分析方法,色谱柱为Agilent Eclipse Plus-C_(18)(4.6 mm×250 mm,5μm),以流动相甲醇-0.1%甲酸水溶液进行梯度洗脱,柱温35℃,流速1.0 m L·min~(-1),检测波长276 nm,采用该方法测定市售10批大株红景天胶囊,并用中药色谱指纹图谱相似度评价系统(2004A)软件进行指纹图谱分析,确定了21个色谱峰作为指纹图谱共有峰,同时对扣除峰面积超过总峰面积50%的单个共有峰前后10批样品的相似度结果进行分析比较,发现10批样品的相似度均大于0.940。采用HPLC/Q-TOF-MS对指纹图谱中的共有峰进行指认,确定了21个共有峰的分子式,结合对照品及质谱信息对其中11个指纹峰进行结构推断。该研究首次采用HPLC建立大株红景天胶囊的指纹图谱并结合HPLC/Q-TOFMS对指纹峰进行指认,该方法具有良好的精密度、稳定性和重复性,为大株红景天胶囊的质量评价提供依据。
A method was established to analyze the fingerprint of Dazhu Hongjingtian capsule by HPLC-DAD. The separation was performed on Agilent Eclipse Plus-C_(18)( 4. 6 mm × 250 mm,5 μm) with methanol-0. 1% formic acid solution as the mobile phase for gradient elution at a flow rate of 1. 0 mL ·min~(-1); the detection wavelength was set at 276 nm and column temperature was set at35 ℃. A total of 10 batches of samples were detected by the above method,and based on their fingerprint by using Similarity Evaluation System for Chromatographic Fingerprint of TCM( 2004A),21 common chromatographic peaks were determined and after the individual common peak whose peak area was greater than 50% of the total peak area was deducted,the similarity results of these samples were analyzed and compared. The results showed that the similarity of 10 batches of samples was all higher than 0. 940. HPLC / Q-TOFMS was used to identify the common chromatographic peaks in the fingerprint and determine the molecular formulas of twenty-one common chromatographic peaks. The structures of 11 fingerprint peaks were tentatively identified based on the control products and mass spectrometry information. This was the first time to establish fingerprint by using HPLC method and identify fingerprint peaks by using HPLC / Q-TOF-MS. This method has good precision,stability and repeatability,and could provide basis for quality evaluation of Dazhu Hongjingtian capsule.

关键词(KeyWords): 大株红景天胶囊;指纹图谱;定性分析;质量评价
Dazhu Hongjingtian capsule;fingerprint;qualitative analysis;quality evaluation

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作者(Author): 刘光大;黄文哲;马世平;王振中;
LIU Guang-da;HUANG Wen-zhe;MA Shi-ping;WANG Zhen-zhong;Jiangsu Kanion Pharmaceutical Co.,Ltd.;China Pharmaceutical University;

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