Research and development of certified reference material of swertioside.
10.19540/j.cnki.cjcmm.20191111.202
- Author:
Cheng SHEN
1
;
Tao CHEN
1
;
Dai-Jie WANG
2
;
Chen CHEN
1
;
Jing-Yang ZHAO
1
;
Ji-Lin CHEN
1
;
Li YANG
1
;
Shuo WANG
1
;
Yu-Lin LI
1
Author Information
1. Northwest Institute of Plateau Biology, Chinese Academy of Sciences Xining 810001, China University of Chinese Academy of Sciences Beijing 101408, China.
2. Shandong Analysis and Testing Center Ji'nan 250000, China.
- Publication Type:Journal Article
- Keywords:
certification;
certified reference material(CRM);
homogeneity;
stability;
swertioside;
uncertainty
- MeSH:
Certification;
Chromatography, High Pressure Liquid;
Mass Spectrometry;
Phytochemicals/standards*;
Reference Standards;
Swertia/chemistry*
- From:
China Journal of Chinese Materia Medica
2020;45(4):955-960
- CountryChina
- Language:Chinese
-
Abstract:
The standard sample of natural products is an essential standard reference to determine the quality of the product in the quality control of natural products. To develop a certified reference material(CRM) of swertioside according to the Work Guideline for Reference Materials(3): Reference Material-General Principles and Statistical Method for Certification(GB/T 15000.3-2008), swertioside was purified from whole plant of Swertia mussotii by extraction, isolation and Prep-HPLC to obtain certified reference material of swertioside. The structure of swertioside was identified by IR, UV, high-resolution MS, NMR. Thin layer chromatography, optical rotation, elemental analysis and melting point was carried out for the identification. The purity of the prepared sample was tested from different chromatographic elution conditions, thin layer chromatography and HPLC-MS. Swertioside was divided into 140 bottles, with 10 mg per bottle after homogeneity test, stability test and quantitative analysis. This CRM is 7-O-[α-L-rhamnopyranosyl-(1→2)-β-D-xylopyranosyl]; the homogeneity of the 95% confidence interval was good; the certified purity value was 98.66%, with a relative expanded uncertainty of 0.38%; the storage period was 36 months at 0-8 ℃. Therefore, the CRM of sakuranetin reached the technical requirements of CRM, and was accepted by SAC. Swertioside is successfully developed and can be used for determining content, evaluating test methods, detecting relevant products and controlling quality.
