摘要
目的:采用均匀设计和JMP软件快速优化头孢克肟颗粒有关物质检测的方法,使系统适应溶液中已知杂质分离度达到基线分离。方法:采用均匀设计和JMP软件,根据模型提出检测方法的设计空间,以保留时间之差(ΔR)作为考察指标。结果:通过均匀设计和JMP软件处理,得到流动相可行的设计空间为pH=6.5±0.25,乙腈23%±2%,25%四丁基氢氧化铵10~13 ml,分离度较好。结论:采用均匀设计和JMP模型处理可以快速优化头孢克肟颗粒有关物质检测的方法,优化后的方法快捷有效。
OBJECTIVE:Uniform design and JMP software were adopted to quickly optimize the detection method of related substances in cefixime particles,so that the system can adapt to the resolution of known impurities to achieve baseline separation.METHODS:Uniform design and JMP software were adopted,design space of detection method based on the model was proposed,and use the difference in retention time(ΔR)as the inspection indicator.RESULTS:Through uniform design and JMP software processing,the feasible design space for mobile phase was pH=6.5±0.25,acetonitrile 23%±2%,25%tetrabutylammonium hydroxide 10-13 ml,with good resolution.CONCLUSIONS:Using uniform design and JMP model processing can quickly optimize the detection method of related substances of cefixime particles,the optimized method is quick and effective.
作者
吴建伟
余俊先
WU Jianwei;YU Junxian(Dept.of Research and Development,Zhejiang Shapuaisi Pharmaceutical Co.,Ltd,Zhejiang Pinghu 314200,China;Dept.of Pharmacy,Beijing Friendship Hospital Affiliated to Capital Medical University,Beijing 100050,China)
出处
《中国医院用药评价与分析》
2020年第10期1216-1220,共5页
Evaluation and Analysis of Drug-use in Hospitals of China
