Uniform Design and Optimization for Impurity Detection of Cefixime Granule

WU Jianwei; YU Junxian

doi:10.14009/j.issn.1672-2124.2020.10.017

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Uniform Design and Optimization for Impurity Detection of Cefixime Granule

更新时间：2022-10-08

- Uniform Design and Optimization for Impurity Detection of Cefixime Granule
- Vol. 20, Issue 10, Pages: 1216-1220(2020)
- 作者机构：
  
  1. 浙江莎普爱思药业股份有限公司研发部
  2. 首都医科大学附属北京友谊医院药学部
- 作者简介：
- 基金信息：
- DOI：10.14009/j.issn.1672-2124.2020.10.017
  CLC： R927
- Published：2020，
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[1]吴建伟,余俊先.头孢克肟颗粒杂质检测的均匀设计及优化[J].中国医院用药评价与分析,2020,20(10):1216-1220.

WU Jianwei, YU Junxian. Uniform Design and Optimization for Impurity Detection of Cefixime Granule. [J]. 20(10):1216-1220(2020)
[1]吴建伟,余俊先.头孢克肟颗粒杂质检测的均匀设计及优化[J].中国医院用药评价与分析,2020,20(10):1216-1220. DOI： 10.14009/j.issn.1672-2124.2020.10.017.

WU Jianwei, YU Junxian. Uniform Design and Optimization for Impurity Detection of Cefixime Granule. [J]. 20(10):1216-1220(2020) DOI： 10.14009/j.issn.1672-2124.2020.10.017.

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p H=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。

Abstract

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

关键词

头孢克肟均匀设计JMP软件设计空间

Keywords

CefiximeUniform designJMP softwareDesign space

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Related Institution

Dept. of Pharmacy, Zhongshan People’s Hospital

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