[Continual improvement of quantitative analytical method development of Panax notogineng saponins based on quality by design].
Zhongguo Zhong Yao Za Zhi
; 42(6): 1095-1103, 2017 Mar.
Article
em Zh
| MEDLINE
| ID: mdl-29027422
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%â¢min⻹ 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.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Saponinas
/
Medicamentos de Ervas Chinesas
/
Panax
Tipo de estudo:
Prognostic_studies
Idioma:
Zh
Revista:
Zhongguo Zhong Yao Za Zhi
Assunto da revista:
FARMACOLOGIA
/
TERAPIAS COMPLEMENTARES
Ano de publicação:
2017
Tipo de documento:
Article
País de afiliação:
China
País de publicação:
CHINA
/
CN
/
REPUBLIC OF CHINA