Continual improvement of quantitative analytical method development of Panax notogineng saponins based on quality by design.
10.19540/j.cnki.cjcmm.20170223.022
- Author:
Sheng-Yun DAI
1
;
Bing XU
1
;
Xin-Yuan SHI
1
;
Xiang XU
2
;
Ying-Qiang SUN
2
;
Yan-Jiang QIAO
1
Author Information
1. Research Center of Traditional Chinese Medicine Information Engineering, Beijing University of Chinese Medicine, Beijing 100029, China.
2. Shandong Buchang Pharmaceutical Co., Ltd., Heze 274000, China.
- Publication Type:Journal Article
- Keywords:
Panax notogineng saponins;
UPLC;
bayesian design space;
continual improvement;
quality by design
- From:
China Journal of Chinese Materia Medica
2017;42(6):1095-1103
- CountryChina
- Language:Chinese
-
Abstract:
This study is aimed to propose a continual improvement strategy based on quality by design (QbD). An ultra high performance liquid chromatography (UPLC) method was developed to accomplish the method transformation from HPLC to UPLC of Panax notogineng saponins (PNS) and achieve the continual improvement of PNS based on QbD, for example. Plackett-Burman screening design and Box-Behnken optimization design were employed to further understand the relationship between the critical method parameters (CMPs) and critical method attributes (CMAs). And then the Bayesian design space was built. The separation degree of the critical peaks (ginsenoside Rg₁ and ginsenoside Re) was over 2.0 and the analysis time was less than 17 min by a method chosen from the design space with 20% of the initial concentration of the acetonitrile, 10 min of the isocratic time and 6%•min⁻¹ of the gradient slope. At last, the optimum method was validated by accuracy profile. Based on the same analytical target profile (ATP), the comparison of HPLC and UPLC including chromatograph method, CMA identification, CMP-CMA model and system suitability test (SST) indicated that the UPLC method could shorten the analysis time, improve the critical separation and satisfy the requirement of the SST. In all, HPLC method could be replaced by UPLC for the quantity analysis of PNS.
