Combination of multi-model statistical analysis and quantitative fingerprinting in quality evaluation of Shuang-huang-li
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RESEARCH PAPER
Combination of multi-model statistical analysis and quantitative fingerprinting in quality evaluation of Shuang-huang-lian oral liquid Wei Si 1,2 & Yali Qiao 1,2 & Zhe Liu 1,2 & Gaowa Jin 1 & Yanfang Liu 1 & Xingya Xue 1 & Han Zhou 1 & Yanming Liu 3 & Aijin Shen 1 & Xinmiao Liang 1 Received: 6 March 2020 / Revised: 6 July 2020 / Accepted: 22 July 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract A model consisting of quantitative fingerprinting integrated with fundamental statistical analysis was established to carry out quality control analysis of Shuang-huang-lian (SHL) oral liquid. The quantitative fingerprinting approach was developed by systematic investigation of the chromatographic condition and optimization of a gradient using a complex sample analysis software system (CSASS). Five pivotal components from three traditional Chinese medicines of SHL oral liquid were determined at dual wavelengths, including phillyrin, baicalin, chlorogenic acid, neochlorogenic acid and cryptochlorogenic acid. Among them, neochlorogenic acid and cryptochlorogenic acid were quantified by quantitative analysis of multi-components with a single marker (QAMS) method. Further, the developed quantitative fingerprinting approach was validated. Good linearity with correlation coefficients (R2) higher than 0.9999 were achieved for phillyrin, baicalin and chlorogenic acid. Recoveries of the three analytes were between 96% and 108%. Relative standard deviation (RSD) values were below 3% regarding the stability and intra-day and inter-day precision. Besides, the feasibility of the QAMS method was verified by an external standard method (ESM) using 18 batches of SHL oral liquid. Fifty-nine batches of SHL oral liquid from nine manufacturers were then analyzed. Effective distinction was realized based on a linear principal component analysis (linear-PCA) model by the combination of the quantitative data and chromatographic fingerprinting. The linear-PCA model based on quantitative chromatographic fingerprinting exhibited great advantage over conventional similarity analysis to distinguish between different samples. The strategy provided a particularly simple and effective approach for quality evaluation of SHL oral liquid from various manufacturers. Keywords Shuang-huang-lian oral liquid . Quantitative fingerprinting . Multi-model statistical analysis . Quality control . Quantitative analysis of multi-components with a single marker
Introduction Wei Si and Yali Qiao contributed equally to this work. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00216-020-02841-z) contains supplementary material, which is available to authorized users. * Aijin Shen [email protected] * Xinmiao Liang [email protected] 1
Key Lab of Separation Science for Analytical Chemistry, Dalian Institute of Chemical Physics, Chinese Academy of Sciences, 457 Zhongshan Road, Dalian 116023, Liaoning, China
2
University of Chinese Academy of Sciences, Beijing 100049, China
3
Shando
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