摘要
目的:本研究对供《中华人民共和国药典》2020年版使用的首批国家药品标准物质盐酸伊达比星进行标定,为我国盐酸伊达比星的质量控制提供保障。方法:综合采用高分辨质谱、核磁共振光谱等技术对盐酸伊达比星标准物质的结构进行确证,并对该化合物的核磁信号进行了准确归属。采用质量平衡法对盐酸伊达比星的含量进行测定,并进一步利用核磁定量法及外标法对上述结果进行佐证,保证了量值的准确。结果:本批盐酸伊达比星标准物质的含量按盐酸伊达比星(C_(26)H_(27)NO_(9)·HCl)计为94.9%。结论:建立了首批盐酸伊达比星标准物质。
Objective:To establish the national drug reference standards of idarubicin hydrochloride applied for the 2020 edition of the Pharmacopoeia,in order to provide guarantee for meeting the standard of quality control of sulfadiazine in China.Methods:The structure of idarubicin hydrochloride was identified by LC-HRMS and NMR.And the NMR signal of idarubicin was accurately assigned.The content of idarubicin hydrochloride was determined by mass balance method,and was further verified by quantitative nuclear magnetic resonance(QNMR)and external standard method to ensure the accuracy of the quantification.Results:The result for the mass balance method was used as the content of idarubicin hydrochloride reference standard,and the amount of idarubicin hydrochloride(C_(26)H_(27)NO_(9) HCl)is 94.9%.Conclusion:The first batch of national standard substances of C_(26)H_(27)NO_(9) HCl was successfully developed.
作者
田冶
崇小萌
刘颖
姚尚辰
TIAN Ye;CHONG Xiao-meng;LIU Ying;YAO Shang-chen(National Institutes forFoodand Drug Control,Beijing 102629,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2022年第17期1747-1751,共5页
Chinese Journal of New Drugs
关键词
盐酸伊达比星
国家药品标准物质
质量平衡法
核磁定量法
结构确证
idarubicin hydrochloride
national drug reference standard
mass balance method
QNMR
structure confirmation
