title: Optimization and Assessment of Three Different High Performance Liquid Chromatographic Systems for the Combinative Fingerprint Analysis and Multi-Ingredients Quantification of Sangju Ganmao Tablet.
abstract: Chromatographic separation is still a critical subject for the quality control of traditional Chinese medicine. In this study, three different high performance liquid chromatographic (HPLC) systems employing commercially available columns packed with 1.8, 3.5 and 5.0 μm particles were respectively developed and optimized for the combinative fingerprint analysis and multi-ingredients quantification of Sangju Ganmao tablet (SGT). Chromatographic parameters including the repeatability of retention time and peak area, symmetry factor, resolution, number of theoretical plates and peak capacity were used to assess the chromatographic performance of different HPLC systems. The optimal chromatographic system using Agilent ZORBAX SB-C18 column (2.1 mm × 100 mm, 3.5 μm) as stationary phase was respectively coupled with diode array detector or mass spectrometry detector for the chromatographic fingerprint analysis and simultaneous quantification or identification of nine compounds of SGT. All the validation data conformed to the acceptable requirements. For the fingerprint analysis, 31 peaks were selected as the common peaks to evaluate the similarities of SGT from 10 different manufacturers using heatmap, hierarchical cluster analysis and principal component analysis. The results demonstrated that the combinations of the quantitative and chromatographic fingerprint analysis offer an efficient way to evaluate the quality consistency of SGT.
authors.affiliation: Jiangsu Key Laboratory of New Drug Research and Clinical Pharmacy, Xuzhou Medical University, Xuzhou, Jiangsu 221004, China.|Department of Pharmaceutical Analysis, Xuzhou Medical University, Xuzhou, Jiangsu 221004, China.
authors.forename: Meng-Zhe
authors.initials: MZ
authors.lastname: Guo
authors.affiliation: Jiangsu Key Laboratory of New Drug Research and Clinical Pharmacy, Xuzhou Medical University, Xuzhou, Jiangsu 221004, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Han
authors.affiliation: Jiangsu Key Laboratory of New Drug Research and Clinical Pharmacy, Xuzhou Medical University, Xuzhou, Jiangsu 221004, China.
authors.forename: Dan-Dan
authors.initials: DD
authors.lastname: He
authors.affiliation: Jiangsu Key Laboratory of New Drug Research and Clinical Pharmacy, Xuzhou Medical University, Xuzhou, Jiangsu 221004, China.
authors.forename: Jia-Hui
authors.initials: JH
authors.lastname: Zou
authors.affiliation: Jiangsu Key Laboratory of New Drug Research and Clinical Pharmacy, Xuzhou Medical University, Xuzhou, Jiangsu 221004, China.
authors.forename: Zheng
authors.initials: Z
authors.lastname: Li
authors.affiliation: Jiangsu Key Laboratory of New Drug Research and Clinical Pharmacy, Xuzhou Medical University, Xuzhou, Jiangsu 221004, China.|Department of Pharmaceutical Analysis, Xuzhou Medical University, Xuzhou, Jiangsu 221004, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Du
authors.affiliation: Jiangsu Key Laboratory of New Drug Research and Clinical Pharmacy, Xuzhou Medical University, Xuzhou, Jiangsu 221004, China.|Department of Pharmaceutical Analysis, Xuzhou Medical University, Xuzhou, Jiangsu 221004, China.
authors.forename: Dao-Quan
authors.initials: DQ
authors.lastname: Tang
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D016000:Cluster Analysis; D004365:Drugs, Chinese Herbal / Q000737:chemistry*; D057230:Limit of Detection; D016014:Linear Models; D013058:Mass Spectrometry / Q000379:methods*; D025341:Principal Component Analysis; D015203:Reproducibility of Results; D013607:Tablets
chemical_list: D004365:Drugs, Chinese Herbal; D013607:Tablets