Establishment and reliability evaluation of the design space for HPLC analysis of six alkaloids in Coptis chinensis(Huanglian) using Bayesian approach

作     者：DAI Sheng-Yun XU Bing ZHANG Yi LI Jian-Yu SUN Fei SHI Xin-Yuan QIAO Yan-Jiang 

作者机构：Research Center of Traditional Chinese Medicine Information Engineering Beijing University of Chinese Medicine Engineering Research Center of Key Technologies for Chinese Medicine Production and New Drug Development Ministry of Education 

基　　金：supported by National Natural Science Foundation of China(No.81403112) Beijing Natural Science Foundation(No.7154217) Scientific Research Program of Beijing University of Chinese Medicine(No.2015-JYB-XS104) Special Program for Beijing Key Laboratory of Chinese Medicine Manufacturing Process Control and Quality Evaluation(No.Z151100001615065) 

出 版 物：《Chinese Journal of Natural Medicines》 (中国天然药物（英文版）)

年 卷 期：2016年第14卷第9期

页      码：697-708页

摘      要：Coptis chinensis(Huanglian) is a commonly used traditional Chinese medicine(TCM) herb and alkaloids are the most important chemical constituents in it. In the present study, an isocratic reverse phase high performance liquid chromatography(RP-HPLC) method allowing the separation of six alkaloids in Huanglian was for the first time developed under the quality by design(Qb D) principles. First, five chromatographic parameters were identified to construct a Plackett-Burman experimental design. The critical resolution, analysis time, and peak width were responses modeled by multivariate linear regression. The results showed that the percentage of acetonitrile, concentration of sodium dodecyl sulfate, and concentration of potassium phosphate monobasic were statistically significant parameters(P < 0.05). Then, the Box-Behnken experimental design was applied to further evaluate the interactions between the three parameters on selected responses. Full quadratic models were built and used to establish the analytical design space. Moreover, the reliability of design space was estimated by the Bayesian posterior predictive distribution. The optimal separation was predicted at 40% acetonitrile, 1.7 g·m L-1of sodium dodecyl sulfate and 0.03 mol·m L-1 of potassium phosphate monobasic. Finally, the accuracy profile methodology was used to validate the established HPLC method. The results demonstrated that the Qb D concept could be efficiently used to develop a robust RP-HPLC analytical method for Huanglian.

主 题 词：Coptis chinensis Quality by Design(Qb D) Bayesian approach Analytical design space Accuracy profile 

学科分类：1007[医学-药学类] 100704[100704] 10[医学] 

核心收录：

D　O　I：10.3724/SP.J.1009.2016.00697

馆 藏 号：203187625...