中国药房2017，Vol.28Issue(36)：5154-5156,3.DOI:10.6039/j.issn.1001-0408.2017.36.30
正交试验优化头孢噻肟钠原料药有关物质检查中溶液制备条件
Optimization of the Solution Preparation in Related Substance Test of Cefotaxime Sodium by Orthogonal Test
张涛 1豆东海 2杨鹏波1
作者信息
- 1. 安阳市食品药品检验检测中心,河南安阳455000
- 2. 河南康达制药有限公司,河南周口 466200
- 折叠
摘要
Abstract
OBJECTIVE:To optimize the solution preparation in related substance test of cefotaxime sodium.METHODS:HPLC method was adopted to determine the total amount of impurities in cefotaxime sodium.Using phosphoric acid buffer solution pH,placing temperature,standing time and illumination as factor,the total amount of impurities as indexes,the preparation condition of solution was optimized by L9(34) orthogonal test.The validation test was carried out.RESULTS:The optimal preparation method was as follows as the sample was dissolved with a solvent containing pH 6.50 phosphate buffer protected from light.The test temperature and the sample temperature were set at 5 ℃,and the sample was injected within 5 min after the preparation of the solution.CONCLUSIONS:The optimized method is reproducible and reliable.关键词
头孢噻肟钠/有关物质/正交试验/测定Key words
Cefotaxime sodium/Related substance/Orthogonal test/Determination分类
医药卫生引用本文复制引用
张涛,豆东海,杨鹏波..正交试验优化头孢噻肟钠原料药有关物质检查中溶液制备条件[J].中国药房,2017,28(36):5154-5156,3.
