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

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• 作者：Sheng-Yun DAI^a ; Bing XU^a ; ^b ; ^{xubing@bucm.edu.cn" class="auth_mail" title="E-mail the corresponding author} ; Yi ZHANG^a ; Jian-Yu LI^a ; Fei SUN^a ; Xin-Yuan SHI^a ; ^b ; Yan-Jiang QIAO^a ; ^b ; ^{yjqiao@263.net" class="auth_mail" title="E-mail the corresponding author}
• 关键词：Coptis chinensis ; Quality by Design (QbD) ; Bayesian approach ; Analytical design space ; Accuracy profile
• 刊名：Chinese Journal of Natural Medicines
• 出版年：2016
• 出版时间：September 2016
• 年：2016
• 卷：14
• 期：9
• 页码：697-708
• 全文大小：4481 K

文摘

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 (QbD) 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·mL⁻¹ of sodium dodecyl sulfate and 0.03 mol·mL⁻¹ of potassium phosphate monobasic. Finally, the accuracy profile methodology was used to validate the established HPLC method. The results demonstrated that the QbD concept could be efficiently used to develop a robust RP-HPLC analytical method for Huanglian.