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Value Assignment Study on a New Certified Reference Material of Cyclovirobuxine D by Differential Scanning Calorimetry Method

[ Vol. 12 , Issue. 6 ]

Author(s):

Li Zhang, Yang Lu, Yonghui Guo, Wei Xu, Guimin Jin and Guanhua Du   Pages 568 - 572 ( 5 )

Abstract:


Cyclovirobuxine D is an active steroid alkaloid distributed in Buxus microphylla and applied in therapeutic practice of cardiovascular disease. This study describes the development of a new CRM, which includes the homogeneity assessment, stability assessment, purity determination, and uncertainty evaluation. DSC method was applied to the value assignment of cyclovirobuxine D for the first time. The certified purity value for the CRM of cyclovirobuxine D is 996.6 mg•g-1 with an extended uncertainty of 0.6 mg•g-1 (k = 2, P = 0.95) by DSC method. The CRM of cyclovirobuxine D can be widely used to quantitative analyses of cyclovirobuxine D and other related pharmaceutical formulations.

Keywords:

Cyclovirobuxine D, DSC, value assignment, uncertainty evaluation, CRM, homogeneity study, stability study.

Affiliation:

Center of Pharmaceutical Polymorph, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P.R. China.

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