Establishment and reliability evaluation of the design space for HPLC analysis of six alkaloids in Coptis chinensis (Huanglian) using Bayesian approach.
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.
Research Center of Traditional Chinese Medicine Information Engineering, Beijing University of Chinese Medicine, Beijing 100029, China.
Sheng-Yun
SY
Dai
Research Center of Traditional Chinese Medicine Information Engineering, Beijing University of Chinese Medicine, Beijing 100029, China; Engineering Research Center of Key Technologies for Chinese Medicine Production and New Drug Development, Ministry of Education, Beijing 100029, China. Electronic address: xubing@bucm.edu.cn.
Bing
B
Xu
Research Center of Traditional Chinese Medicine Information Engineering, Beijing University of Chinese Medicine, Beijing 100029, China.
Yi
Y
Zhang
Research Center of Traditional Chinese Medicine Information Engineering, Beijing University of Chinese Medicine, Beijing 100029, China.
Jian-Yu
JY
Li
Research Center of Traditional Chinese Medicine Information Engineering, Beijing University of Chinese Medicine, Beijing 100029, China.
Fei
F
Sun
Research Center of Traditional Chinese Medicine Information Engineering, Beijing University of Chinese Medicine, Beijing 100029, China; Engineering Research Center of Key Technologies for Chinese Medicine Production and New Drug Development, Ministry of Education, Beijing 100029, China.
Xin-Yuan
XY
Shi
Research Center of Traditional Chinese Medicine Information Engineering, Beijing University of Chinese Medicine, Beijing 100029, China; Engineering Research Center of Key Technologies for Chinese Medicine Production and New Drug Development, Ministry of Education, Beijing 100029, China. Electronic address: yjqiao@263.net.
Yan-Jiang
YJ
Qiao
D000470:Alkaloids / Q000032:analysis* / Q000302:isolation & purification; D001499:Bayes Theorem; D002851:Chromatography, High Pressure Liquid / Q000379:methods / Q000592:standards*; D056148:Chromatography, Reverse-Phase / Q000295:instrumentation / Q000379:methods; D039323:Coptis / Q000737:chemistry*; D004365:Drugs, Chinese Herbal / Q000032:analysis* / Q000302:isolation & purification
D000470:Alkaloids; D004365:Drugs, Chinese Herbal
Accuracy profile; Analytical design space; Bayesian approach; Coptis chinensis; Quality by Design (QbD)