IDENTIFICATION AND DETERMINATION OF THE CHEMICAL CONSTITUENTS IN A HERBAL PREPARATION, COMPOUND KUSHEN INJECTION, BY HPLC AND LC-DAD-MS/MS

The qualitative and quantitative analyses by HPLC and LC-DAD-MS/MS were conducted for the quality consistency evaluation of Compound Kushen Injection (CKI). For fingerprint analysis, 8 peaks were selected as the characteristic peaks in the HPLC chromatograms of 27 different batches of CKI samples and their similarities were more than 0.90, except the four samples. For the typical HPLC profile, peak identification was carried out by HPLC and LC-MS/MS analyses and as a result, 21 chromatographic peaks were identified or characterized based on the comparison of retention time and UV spectra with authentic compounds as well as by summarized MS fragmentation rules. Six of these identified compounds, including oxymatrine, oxysophocarpine, N-methylcytisine, matrine, sophocarpine, and trifolirhizin, were simultaneously determined and the results showed that the total amounts of six marker compounds were variable, to some extent, which was deduced to be related to the quality of the crude materials and the manufacturing process employed. Supplemental materials are available for this article. Go to the publisher's online edition of the Journal of Liquid Chromatography & Related Technologies to view the supplemental file.