SHANDONG SCIENCE ›› 2018, Vol. 31 ›› Issue (1): 16-.doi: 10.3976/j.issn.1002-4026.2018.01.003

• Traditional Chinese medicine and natural active products • Previous Articles     Next Articles

Preparation of certified reference materials of hesperetin

SONG Xiang-yun1, LIU Jin-yu2, GENG Yan-ling1, LIN Yun-liang1, FU Rui-ming1, CUI Li1, WANG Dai-jie1*   

  1. 1.Shandong Provincial Key Laboratory of TCM Quality Control, Shandong Analysis and Test Center, Jinan 250014, China;
    2. Lunan Pharmaceutical Group Co., Ltd., Linyi 276006, China
  • Received:2017-10-19 Online:2018-02-20 Published:2018-02-20

Abstract:

A method for the preparation of the certified reference material (CRM) of hesperetin was established in this article. Hesperetin sample was obtained by means of silica gel chromatography combined with preparative HPLC technique, and its structure was characterized by UV, IR, MS and NMR. At the same time, the TLC identification and thermogravimetric analysis were carried out, and the sample was divided into bottles for further homogeneity test, stability test, and the cooperative certification by 8 laboratories. The results indicated that hesperetin samples had good homogeneity, with good stability within 12 months at 0~4 ℃. The certified value of the reference material of hesperetin was 98.78%, with the expanded uncertainty of 0.26% in confidence coefficient of 95%. The standard sample of hesperetin has reached the technical requirements of the national certified reference material. The CRM has traceability and can be used in the content determination, testing method validation, as well as t quality control of hesperetin and related products.

Key words: hesperetin, certified reference material, stability, certification, uncertainty, homogeneity

CLC Number: 

  • R284.2