Development of an analytical method by defining a design space: a case study of saponin determination for Panax notoginseng extracts

作者：Gong, Xingchu; Zhang, Ying; Chen, Huali; Chen, Teng; Pan, Jianyang; Wang, Xiaoyu; Qu, Haibin^*

来源：Analytical Methods, 2016, 8(10): 2282-2289.

DOI：10.1039/c5ay03119b

• PERFORMANCE LIQUID-CHROMATOGRAPHY
• OPTIMIZATION STRATEGY
• HPLC-ELSD
• SEPARATION
• DRUGS

A reversed-phase HPLC-UV method was developed using a design space approach for the simultaneous determination of five saponins in the extracts of Panax notoginseng, which were notoginsenoside R-1, ginsenosides Rg(1), Re, Rb-1, and Rd. In the development of this method, resolutions of three critical peak pairs were considered as critical quality attributes (CQAs). The effects of four parameters on gradient elution were quantitatively investigated. Design space with a probability to attain CQA criteria higher than 0.9 was calculated using a Monte-Carlo simulation method. Several gradients were optimized in this work. The newly developed method was validated and can be used for saponin concentration determination of Panax notoginseng extracts.

• 出版日期2016
• 单位浙江大学