目的 建立虎地肠溶胶囊多成分定量方法,并结合化学计量学方法对其进行质量评价.方法 采用超高效液相色谱—四极杆静电场轨道阱高分辨质谱法(ultra-performance liquid chromatography-quadrupole-electrostatic field Orbitrap high-resolution mass spectrometry,UPLC-Orbitrap-HRMS)测定10批虎地肠溶胶囊中没食子酸、虎杖苷、甘草酸、白藜芦醇、鞣花酸、甘草素、甘草苷、大黄素、绿原酸、异甘草素、咖啡酸、木犀草素、芒柄花素、芹菜素、槲皮素和山柰酚的含量,并采用聚类分析、主成分分析、正交偏最小二乘法判别分析和灰色关联度分析对样品进行综合评价.结果 16个成分线性关系良好,专属性、精密度、重复性、稳定性和平均加样回收率实验均符合标准.10批虎地肠溶胶囊被分为2类,甘草素、木犀草素、白藜芦醇、鞣花酸、槲皮素、山柰酚、咖啡酸、绿原酸和大黄素9个成分对样品质量的差异影响较大;以质量优劣情况对样品进行排序,第Ⅰ类样品的质量普遍劣于第Ⅱ类,木犀草素、鞣花酸、槲皮素、山柰酚、绿原酸和大黄素6个成分的含量偏低可能是第Ⅰ类样品质量低劣的原因.结论 建立的虎地肠溶胶囊多成分定量方法结合化学计量学分析可用于该药物的质量评价.
Quality Assessment of Hudi Enteric-coated Capsules Based on UPLC-Orbitrap-HRMS Multi-component Determination Combined with Chemometrics
Objective To establish a multi-component quantitative method for Hudi Enteric-coated Capsule (HDEC),and to e-valuate the quality of HDEC in combination with chemometrics.Methods Ultra performance liquid chromatography-quadru-pole/electrostatic field orbitrap high resolution mass spectrometry (UPLC-Orbitrap HRMS)was used to measure the content of gallic acid,polydatin,glycyrrhizic acid,resveratrol,ellagic acid,liquiritigenin,liquiritin,emodin,chlorogenic acid,isoliquiri-tigenin,caffeic acid,luteolin,formononetin,apigenin,quercetin,and kaempferol in 10 batches of HDEC,and cluster analy-sis,principal component analysis,orthogonal partial least square-discriminant analysis,and grey correlation analysis were used for comprehensive assessment of the samples.Results The 16 components had a good linear relationship,and the specificity,precision,repeatability,stability,and average recovery of the experiments all met related standards.The 10 batches of HDEC were divided into two classes,and the 9 components of liquiritigenin,luteolin,resveratrol,ellagic acid,quercetin,kaempferol,caffeic acid,chlorogenic acid,and emodin had a great impact on the quality of the samples.According to the quality of the sam-ples,the quality of the samples in class Ⅰ was worse than that in class Ⅱ,and the low content of luteolin,ellagic acid,quer-cetin,kaempferol,chlorogenic acid,and emodin might be the reason for the poor quality of the samples in class Ⅰ. Conclusion The established multi-component quantitative method combined with chemometrics analysis can be used for the quality assessment of HDEC.
万方数据
维普
