HPLC法测定注射用头孢他啶的含量
Determination of the Ceftazidime for Injection by HPLC
谷海泽 1表亚囡 1焦云飞 1杨轩 1巩海雪 1杨梦德 1谷艺凡1
作者信息
- 1. 华北制药河北华民药业有限责任公司河北省头孢类药物制备技术创新中心,河北石家庄 052165
- 折叠
摘要
建立一种高效液相色谱法(HPLC)测定注射用头孢他啶含量.经过验证:该方法的系统精密度(峰面积RSD)为0.19％(n=6),重复性(RSD)为0.12％,中间精密度(RSD)为1.38％,线性范围为61.295 5～214.534 3 μg/mL,平均回收率为101.30％(RSD为0.25％).该方法专属性、精密度、线性、耐用性等参数符合要求,可用于测定注射用头孢他啶的含量.
Abstract
A HPLC method was established for determining the content of the Ceftazidime for injection.The systematic precision(peak area RSD)of the method was 0.19％(n=6),the repeatability(RSD)was 0.12％and the intermediate precision(RSD)was 1.38％,the linear range was from 61.295 5 μg/mL to 214.534 3 μg/mL,the average recovery rate was 101.30％,with the RSD of 0.25％.The specificity,precision,linearity and robustness of the method meet the requirements,and can be used to determine the content of the Ceftazidime for injection.
关键词
含量/注射用头孢他啶/高效液相色谱法/方法学验证Key words
content/Ceftazidime for injection/HPLC/methodological verification引用本文复制引用
出版年
2024
NETL
NSTL
万方数据