Purity and Uncertainty Study of CRM Betulin by DSC

Li Zhang,De-Zhi Yang,Fu-Qing Wang,Bao-Xi Zhang,Yan-Cai Bi,Peng-Hui Yuan,Guan-Hua Du,Yang Lu,Bin Su

doi:10.1007/s13659-020-00261-1

Abstract

Betulin (BE) can be obtained from many plants, such as those belonging Betulaceae family, and pharmacological investigations showed its notable biological properties and good potential for food and pharmaceutical development. We investigated the homogeneity, stability, purity, and uncertainty of a newly certified reference material (CRM) of BE. The certified purity value for the CRM of BE was 99.56% with an extended uncertainty of 0.07% (k = 2, P = 0.95), as determined by differential scanning calorimetry (DSC). In this study, DSC was used for the first time for purity determination of BE. Given its high accuracy, precision, and reproducibility, DSC can be used as an alternative technique for purity determination of CRMs in the pharmaceutical and food industry.Graphic abstract

Highlights

Betulin [BE; betulinol, 3β-lup-20(29)-en-3,28-diol] belongs to a class of pentacyclic triterpenes and is the predominant compound of the outer bark of birch tree (Betula) [1]
The purity of the certified reference material (CRM) of BE was estimated at 99.56% ± 0.07% (k = 2) within a typical 95% confidence interval based on the combined value assignments and the Uc by differential scanning calorimetry (DSC)
The uncertainty of CRM arising from uB1(DSC), u A1(DSC), u B2(DSC), u B3(DSC), and u B4(DSC) were calculated and discussed

Summary

Introduction

Betulin [BE; betulinol, 3β-lup-20(29)-en-3,28-diol] belongs to a class of pentacyclic triterpenes and is the predominant compound of the outer bark of birch tree (Betula) [1]. Pharmacological investigations have revealed that BE has many notable biological properties, such as anti-bacterial, anti-inflammatory, anti-fungal, and anti-viral effects, that work effectively on lesions; it . 1 1.97 138.98 2 2.21 154.68 3 2.81 198.36 4 3.27 225.11 5 3.68 251.13 6 4.12 281.93 quantitative analyses, verification, the study of homogeneity and stability, purity determination, and uncertainty evaluation. In the current article, the CRM of BE was investigated and described by DSC for the first time. The establishment of an accurate quantitative analysis method for BE is essential to enhance its utilization

Methods

Results

Conclusion