Development of a novel method combining HPLC fingerprint and multi-ingredients quantitative analysis for quality evaluation of traditional Chinese medicine preparation. Yang Dong-Zhi,An Yi-Qiang,Jiang Xiang-Lan,Tang Dao-Quan,Gao Yuan-Yuan,Zhao Hong-Tao,Wu Xiao-Wen Talanta A novel method combining high performance liquid chromatography (HPLC) fingerprint and simultaneous quantitative analysis of multiple active 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, simultaneous 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. 10.1016/j.talanta.2011.04.059

Multiple fingerprint profiling for quality evaluation of polysaccharides and related biological activity analysis of Chinese patent drugs: Zishen Yutai Pills as a case study. Li Hongyi,Cao Jiliang,Wu Xu,Deng Yun,Ning Na,Geng Chunxian,Lei Ting,Lin Ruizhen,Wu Dingtao,Wang Shengpeng,Li Peng,Wang Yitao Journal of ethnopharmacology ETHNOPHARMACOLOGICAL RELEVANCE:Zishen Yutai Pills (ZYP), a famous traditional Chinese patent medicine, has been widely applied to avoid recurrent miscarriage and treat threatened abortion. Polysaccharides of ZYP (ZYPPs) play an essential role in the theraprutic effects of ZYP. However, the complex compositions of ZYP and the complicated structure of ZYPPs have posed great challenges and barriers to the quality evaluation of ZYP. AIM OF THE STUDY:To identify and characterize the ZYPPs for better quality control of ZYP, a reliable and valid quality control system was established in this study. MATERIALS AND METHODS:A multi-fingerprint profile strategy based on HPSEC-MALL-RID, FT-IR, and HPLC (complete acid digested fingerprint, partial acid digested fingerprint and enzymatically digested fingerprint) was established to identify and discriminate the chemical structure of ZYPPs. Besides, the purpose of revealing the relationships between structure and biological activity of ZYPPs, their chemical characteristics, in vitro antioxidant and anti-glycation activities were investigated and discussed. RESULTS:The similarity evaluation of ZYPPs indicated ZYPPs from different batches showed a high similarity based on the correlation coefficient values of multi-fingerprints. Furthermore, ZYPPs exhibited remarkable antioxidant and antiglycation properties, which might be attributed to their molecular weights and the content of uronic acids. CONCLUSIONS:These results indicated that the multiple fingerprint technique was reliable and effective for the improvement of quality control of ZYPPs, suggesting the multiple fingerprint technique could also be potentially applied as a valid and feasible strategy to control the quality of polysaccharide-enriched herbal medicines. 10.1016/j.jep.2020.113045

Establishing the chromatographic fingerprint of traditional Chinese medicine standard decoction based on quality by design approach: A case study of Licorice. Zhang Hui,Wang Jianan,Chen Yan,Shen Xiaowei,Jiang Huijie,Gong Xingchu,Yan Jizhong Journal of separation science A novel analytical quality by design approach for developing a chromatographic fingerprint was established for analyzing complex traditional Chinese medicine, using a licorice standard decoction as an example. Considering the characteristics of integrity and ambiguity, the resolution of eight common peaks, total peak number, capacity factor distributions, and peak purity were selected as potential critical method attributes for assessing the quality of the chromatographic fingerprint. A central composite design was used to evaluate the relationship between critical method attributes and critical method parameters, including column temperature, wavelength, flow rate, formic-acid concentration, and gradient parameters. A standard probability method was employed to calculate the design space of the fingerprint analysis parameters and evaluate the robustness of the methodology. The optimized high-performance liquid chromatography fingerprint conditions were acetonitrile and 0.1% formic acid water gradient elution (0-5 min, 5-19% A; 5-10 min, 19% A; 10-50 min, 19-42% A; 50-54 min, 42-100% A; 54-60 min, 100% A), column temperature 25±5°C, detection wavelength 265 nm. The design space of fingerprint analytical method based on the analytical quality by design approach not only met the requirements of the fingerprint analysis, but also improved the robustness and applicability of the fingerprint method. 10.1002/jssc.201800989

Development of a comprehensive method combining UHPLC-CAD fingerprint, multi-components quantitative analysis for quality evaluation of Zishen Yutai Pills: A step towards quality control of Chinese patent medicine. Cao Jiliang,Lei Ting,Wu Sijia,Li Hongyi,Deng Yun,Lin Ruizhen,Ning Na,Geng Chunxian,Wang Shengpeng,Wu Xu,Li Peng,Wang Yitao Journal of pharmaceutical and biomedical analysis Zishen Yutai Pills (ZYP) is a well-known Chinese patent medicine which has been used to prevent recurrent miscarriage and treat threatened abortion in China. In this study, a comprehensive strategy combining ultrahigh performance liquid chromatography coupled with charged aerosol detector (UHPLC-CAD) fingerprint and multi-components quantitative analysis was developed and validated for quality evaluation of ZYP. For fingerprint analysis, a total of 52 characteristic peaks were selected to evaluate the similarities of 16 batches of ZYP. In addition, combining the chemical fingerprint profile with an advanced hybrid LTQ-Orbitrap mass spectrometer, 281 compounds were identified or tentatively identified in ZYP based on chemical standards, accurate mass and fragmentation information. Moreover, 18 chemical markers were simultaneously determined within 13 min by ultra-performance liquid chromatography couple to tandem mass spectrometry (UPLC-MS/MS) with positive-negative conversion multiple reaction monitor (+/-MRM) technique. This method has been validated and exhibited satisfactory sensitivity, precision, reproducibility and accuracy. The validated quantitative method was successfully applied to the analysis of 16 batches of ZYP samples. The combination of UHPLC-CAD fingerprint and multi-components quantification has been proved to be an efficient and reliable strategy for quality control of ZYP and could be considered as a reference for quality evaluation of Chinese patent medicine. 10.1016/j.jpba.2020.113570