Abstract

Flavonoids are the most widely used in the field of the food, medicine, and cosmetic due to their pharmacological functions and biological activities, such as anti-tumor, anti-inflammatory and antioxidation. This work described the assignment of purity values to 3 flavonoids certified reference materials (CRMs) including baicalein, 5,7-dihydoxy flavones and naringenine which were developed in this study according to the ISO Guides 34 and 35. The qualitative analysis was performed by liquid chromatography-mass spectrometry (LC-MS) and infrared spectroscopy (IR). The CRMs’ purity values were assigned based on the weighted average of quantitative nuclear magnetic resonance method and mass balance approach with high resolution liquid chromatography-VWD. All the three CRMs with following value mass fractions: baicalein at a certified purity P ± U (k = 2) of 98.8% ± 0.8%; 5,7-dihydoxy flavones of 99.1% ± 0.7% and naringenine of 99.5% ± 1.0% respectively. The homogeneity of the CRMs was determined by an in-house validated liquid chromatographic method. Potential degradation during storage was also investigated and a shelf-life based on this value was established.

Highlights

  • A certified reference material (CRM) is a material or substance whose one or more property values are sufficiently homogeneous, stable, and well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials [1]

  • This paper describes the development of three flavonoids CRMs including baicalein, 5,7-dihydoxy flavones and naringenine

  • liquid chromatographymass spectrometry (LC-MS) Method The experiment obtained the molecular weight of the flavonoids CRMs by full scan mass spectra

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Summary

INTRODUCTION

A certified reference material (CRM) is a material or substance whose one or more property values are sufficiently homogeneous, stable, and well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials [1]. The qualities of flavonoids products will have analytical challenges. The flavonoids CRMs have been determined by at least two independent analytical methods. The flavonoids CRMs could be used to ensure the accuracy, traceability and comparability of the related products test results. The moisture content and inorganic elements content were determined by Karl Fischer titration, inductively coupled plasma mass spectrometry (ICP-MS), respectively. Homogeneity study was evaluated by F-test and t-test both for between vials and within vial. The uncertainties of CRMs were evaluated extensively

Materials
Instrument
Qualitative Analysis Methods
Quantitative Analysis Methods
Homogeneity Study and Stability Study
Uncertainty Evaluation
CONCLUSION
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