title: Ultra-high performance liquid chromatography coupled with quadrupole/time of flight mass spectrometry based chemical profiling approach for the holistic quality control of complex Kang-Jing formula preparations.
abstract: The Kang-Jing (KJ) formula is a compound preparation made from 12 kinds of herbs. So far, four different methods (M1-M4) have been documented for KJ preparation, but the influence of preparation methods on the holistic quality of KJ have remained unknown. In this study, a strategy was proposed to investigate the influence of different preparation methods on the holistic quality of KJ using ultra-high performance liquid chromatography coupled with quadrupole/time of flight mass spectrometry (UHPLC-QTOF-MS/MS) based chemical profiling. A total of 101 compounds mainly belonging to flavonoids, tanshinones, monoterpene glycosides, triterpenoid saponins, alkaloids, phenolic acids and volatile oils, were identified. Among these compounds, glaucine was detected only in M3/M4 samples, while two dehydrocorydaline isomers merely detected in M2/M3/M4 samples. Tetrahydrocolumbamine, ethylic lithospermic acid, salvianolic acid E and rosmarimic acid were only detected in M1/M3/M4 samples. In the subsequent quantitative analysis, 12 major compounds were determined by UHPLC-MS/MS. The proposed method was validated with respect to linearity, accuracy, precision and recovery. It was found that the contents of marker compounds varied significantly in samples prepared by different methods. These results demonstrated that preparation method does significantly affect the holistic quality of KJ. UHPLC-QTOF-MS/MS based chemical profiling approach is efficient and reliable for comprehensive quality evaluation of KJ. Collectively, this study provide the chemical evidence for revealing the material basis of KJ, and establish a simple and accurate chemical profiling method for its quality control.
authors.affiliation: R&D Center, Jiangsu Shenlong Pharmaceutical Co., Ltd., Yancheng 224200, China; School of Traditonal Chinese Medicine, China Pharmaceutical University, Nanjing 210009, China.
authors.forename: Xiao-Huan
authors.initials: XH
authors.lastname: Yang
authors.affiliation: Laboratory of Cellular and Molecular Biology, Jiangsu Province Academy of Traditional Chinese Medicine, Nanjing 210028, China.
authors.forename: Xiao-Lan
authors.initials: XL
authors.lastname: Cheng
authors.affiliation: School of Pharmacy, China Pharmaceutical University, Nanjing 210009, China.
authors.forename: Bing
authors.initials: B
authors.lastname: Qin
authors.affiliation: R&D Center, Jiangsu Shenlong Pharmaceutical Co., Ltd., Yancheng 224200, China.
authors.forename: Zhuo-Ya
authors.initials: ZY
authors.lastname: Cai
authors.affiliation: R&D Center, Jiangsu Shenlong Pharmaceutical Co., Ltd., Yancheng 224200, China.
authors.forename: Xiong
authors.initials: X
authors.lastname: Cai
authors.affiliation: R&D Center, Jiangsu Shenlong Pharmaceutical Co., Ltd., Yancheng 224200, China.
authors.forename: Shao
authors.initials: S
authors.lastname: Liu
authors.affiliation: R&D Center, Jiangsu Shenlong Pharmaceutical Co., Ltd., Yancheng 224200, China. Electronic address: cpuwangqi@163.com.
authors.forename: Qi
authors.initials: Q
authors.lastname: Wang
authors.affiliation: R&D Center, Jiangsu Shenlong Pharmaceutical Co., Ltd., Yancheng 224200, China; School of Traditonal Chinese Medicine, China Pharmaceutical University, Nanjing 210009, China. Electronic address: qyjason@163.com.
authors.forename: Yong
authors.initials: Y
authors.lastname: Qin
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D013058:Mass Spectrometry / Q000379:methods*; D008516:Medicine, Chinese Traditional; D011786:Quality Control
keywords: Chemical profiling; Kang-Jing (KJ) formula; Quality control; Quantitative analysis; UHPLC-QTOF-MS/MS