白癜风胶囊HPLC指纹图谱研究

HPLC Fingerprint Analysis of Baidianfeng Capsule

目的建立不同厂家白癜风胶囊HPLC指纹图谱,研究不同厂家白癜风胶囊的差异性,为科学评价白癜风胶囊的质量提供理论依据。方法采用XBridge® Shield RP18色谱柱(4.6 mm×250 mm,5μm),流速1 mL·min^-1,甲醇-0.15%甲酸溶液梯度洗脱,检测波长300 nm,柱温35℃。建立制剂HPLC指纹图谱使用中药色谱指纹图谱相似度评价系统(2008年版)计算相似度;采用HPLC-MS法通过对照品比对及文献检索对共有峰进行指认,确定其来源。结果方法学考察显示,建立的HPLC指纹图谱精密度、稳定性、重复性均可满足指纹图谱分析的需要;对指纹图谱中的18个共有峰进行了指认;10批样品的指纹图谱相似度评价结果在0.723~0.900,表明不同样品的质量差异较大。结论该HPLC指纹图谱检测方法稳定可靠且重现性好,可以有效控制白癜风胶囊质量,为完善其质量标准提供了科学依据。

OBJECTIVE To establish an HPLC chromatographic fingerprint analysis method for the quality evaluation of Baidianfeng capsule and study the differences of products from different manufacturers.METHODS The chromatographic separation was performed on an XBridge®Shield RP18 column(4.6 mm×250 mm,5 μm),with the mixture of methanol and 0.15% formic acid as mobile phases in gradient elution mode.The detection wave length was set at 300 nm,the flow rate was 1.0 mL·min^-1 and the column temperature was maintained at 35℃.The similarity was evaluated with Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(version 2008).Common peaks were identified by HPLC-MS through the comparison with the references and literature.RESULTS The precision,repeatability and stability of the established method can meet the requirements of fingerprint chromatography analysis.There were 18 common peaks were identified in the HPLC fingerprint.The similarity of 10 batches of samples ranged from 0.723 to 0.900,indicating greater differences in the qualities among the samples.CONCLUSION The developed method could provide the comprehensive information about the chemical components in Baidianfeng capsule in a rapid reliable and convenient manner.It could be used in quality evaluation of the drug.It provides scientific basis for improving its quality standard.