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Abstract: A novel method combining high performance liquid chromatography (HPLC) fingerprint and simultanous quantitative analysis of multiple acitve components was developed and validated for quality evaluation of one type of traditional Chinese medicine preparations: Shuang-huang-lian (SHL) oral liquid formulation. For fingerprint analysis, 45 peaks were selected as the common peaks to evaluate the similarities among several different SHL oral liquid preparations collected from manufacturers. Additionally, simultanous quantification of eleven markers, including chlorogenic acid, caffeic acid, rutin, forsythiaside, scutellarin, baicalin, forsythin, luteoloside, apigenin, baicalein and wogonin, was performed. Statistical analysis of the obtained data demonstrated that our method has achieved desired linearity, precision and accuracy. Finally, concentrations of these eleven markers in SHL oral liquid prepared by different manufacturers in China were determined. These results demonstrated that the combination of HPLC chromatographic fingerprint and simultaneous quantification of multi-ingredients offers an efficient and reliable approach for quality evaluation of SHL oral liquid preparations. [Copyright &y& Elsevier]

A combinative method using fingerprint analysis (FA) and multi-ingredients quantification (MIQ) was developed and validated for the quality control of Yinhuang (YH) preparations including granule, capsule, and lozenge by high-performance liquid chromatography coupled with diode array detection (HPLC-DAD). Common peaks with or without standard references in FA were confirmed or identified by electrospray ionization tandem mass spectrometry (ESI-MS/MS). The chromatographic separations were achieved on a Sepax GP-C column (250 mm × 4.6 mm i.d., 5 μm) with a gradient elution using a mixture of 0.1 % formic acid methanol solution and 0.1 % formic acid water solution. In quantitative analysis, nine bioactive constituents (chlorogenic acid, caffeic acid, luteoloside, baicalin, luteolin, wogonoside, baicalein, wogonin, and oroxylin A) were simultaneously determined. The detection wavelength was set at 275 nm, 320 nm, and 350 nm according to the absorption properties of the nine quantified compounds. The linearity, recovery, intraday and interday precision, accuracy, limit of detection (LOD) and quantification (LOQ), repeatability and stability were all tested and good results were obtained. In the FA, 320 nm was selected. The correlation coefficients of similarity were determined on the basis of the relative retention time (RRT) and relative peak area (RPA) of 20 common peaks in chromatographic fingerprints. Results indicated that both the RRT and RPA of 20 common peaks shared a close similarity. From the 20 common peaks, 18 compounds, including the nine quantified compounds, were identified or tentatively characterized by comparing their retention times, UV spectra, and MS spectra with those of standard compounds or literature data. The study not only presents a powerful and reliable analytical tool for the quality control of YH preparations, but also provides the chemical evidence for revealing the material basis of their therapeutic effects. [Figure not available: see fulltext.] [ABSTRACT FROM AUTHOR]