摘要
目的:改进2010年版《中国药典》一部环维黄杨星D的含量测定方法。方法:对2010年版《中国药典》一部环维黄杨星D含量测定法进行方法学验证,考察环维黄杨星D含量测定供试液稳定性,并采用LC-MS法对环维黄杨星D含量测定供试液进行分析。结果:该含量测定法中加入的醋酐与环维黄杨星D发生了反应,生成了环维黄杨星D的乙酰化产物。结论:控制该方法中冰醋酸的含水量(≤0.21%),不需加入醋酐即可准确测定环维黄杨星D含量。
Objective： To improve the quality assay analytic method of cyclovirobuxine D in Chinese Pharmacopoeia 2010 edition （Vol Ⅰ）. Methods： The assay method of cyciovirobuxine D was validated by Chinese Pharmacopoeia 2010 edition and the stability of the test solution was measured. The method of LC-MS was applied to analyzing the test solution of cyclovirobuxine D. Results： The experiment showed that cyclovirobuxine D did react with the adding acetic anhydride and the acetylated products were generated. Conclusion： The content of cyclovirobuxine D can be measured without adding acetic anhydride when the water content in glacial acetic acid can be con-trolled（ ≤0. 21% ）.
出处
《中国药品标准》
CAS
2013年第3期190-193,共4页
Drug Standards of China
