摘要
采用质量平衡法(包括有关物质、残留溶剂、水分和炽灼残渣)、容量法与定量核磁共振法(qNMR)3种不同原理的方法对阿考替胺盐酸盐三水合物(C_(21)H_(30)N_4O_5S·HCl·3H_2O)对照品进行定值分析,定值结果以C_(21)H_(30)N_4O_5S·HCl计。质量平衡法结果为89.67%,容量法结果为89.92%,定量核磁共振法结果为89.30%。3种方法相互验证,更好地保证了对照品定值结果的准确性,为缺乏法定标准物质的对照品定值提供参考。
The purity of acotiamide hydrochloride hydrate （C21H30N4O5S·HCl·3H2O） was determined by mass balance method （including related substances, residual solvents, water and residue on ignition）, volumetric method and quantitative nuclear magnetic resonance method （qNMR）, respectively. The results of the certified value of C21H30N4O5S·HCl were 89.67%, 89.92% and 89.30% by the above three methods, respectively. The results indicated that three methods could be verified by each other. The paper gave a way to assure the determination accuracy of acotiamide hydrochloride hydrate as the reference substance and provided some references for the evaluation of reference materials which is not officially available.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2017年第12期1780-1785,共6页
Chinese Journal of Pharmaceuticals
