Objective: According to the JJF 1343 general and statistical principles for characterization of reference material,to establish methods for the characterization of schizandrin A and evaluate the uncertainty. Methods: The purity of organic substance was determined by high performance liquid chromatography, and the contents of water, residual solvents and inorganic impurities were determined at the same time.Then the content of schisandrin A was calculated by mass balance (MB) method and quantitative nuclear magnetic resonance(qNMR) method. The average content obtained from MB and qNMR methods was used to be the characterization result of schisandrin A after statistical analysis, andthe uncertainty was evaluated. Results: The characterization result of schizandrin A was 99.3%, with the uncertainty of 0.4%(k=2). Conclusion: The established method can be used for the determination of schizandrin A and similar purity reference materials. The schizandrin A is approved as a national CRM(GBW (E) 091113). The CRM can be used for the content determination, quality control, analytical instrument calibration and analytical method confirmation, etc.
XU Ji-feng, WANG Zheng-tao, PAN Xue-ge, WANG Feng-qi, ZHANG Tian-yong, XIE Tian-pei, QIAN Yong
. Characterization and uncertainty evaluation of schizandrin A purity reference material[J]. Chinese Journal of Pharmaceutical Analysis, 2022
, 42(7)
: 1278
-1285
.
DOI: 10.16155/j.0254-1793.2022.07.22
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