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机构地区:[1]浙江中医药大学,杭州310053 [2]浙江省食品药品检验研究院,杭州310004
出 处:《医药导报》2014年第10期1360-1364,共5页Herald of Medicine
基 金:国家科技部"十二五"资助项目中药质量标准研究和信息化体系建设平台(2012ZX09304-005)
摘 要:目的建立五子衍宗丸的高效液相色谱(HPLC)指纹图谱。方法使用Agilent Extend C18(250 mm×4.6 mm,5μm)色谱柱,柱温30℃,以乙腈-甲醇(10∶1)和0.4%磷酸为流动相,梯度洗脱,流速1.0 mL·min-1,检测波长254 nm,并利用液相色谱-质谱(LC-MS)对主要色谱峰进行指认。结果根据LC-MS数据、对照品比对或文献参照对10个共有峰中的9个色谱峰进行了指认。用建立的对照指纹图谱测定16批五子衍宗丸,其相似度均>0.93。结论该方法精密度、稳定性、重复性良好。该方法为五子衍宗丸的全面质量评价奠定基础。Objective To establish the high performance liquid chromatography( HPLC) fingerprint of wuzi yanzong pills. Methods HPLC was performed on Agilent Extend C18column(250 mm × 4. 6 mm,5 μm) with a gradient elution system using acetonitrile:methanol(10∶ 1)-0. 4% phosphoric acid as the mobile phase. The column temperature was set at 30 ℃ and the flow rate was 1. 0 mL·min^-1. The eluate was detected at the wavelength of 254 nm. Chromatographic peaks were identified by LC-MS method. Results Nine common peaks in wuzi yanzong pill samples were identified by comparing their LC-MS data with those of reference compounds and related reference reports. The HPLC fingerprint of wuzi yanzong pills was finally developed based on the analysis of sixteen batches of samples and their similarities were above 0. 93. Conclusion This method has high precision,stability and repeatability. This study could be used for overall quality assessment of wuzi yanzong pills.
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