高效液相色谱法测定碘佛醇注射液中乙二胺四醋酸二钠钙的含量
Determintion of Calcium Disodium Edetate in Ioversol Injection by HPLC
李纯璞 1王习文 1余小翠 1张贵英 1赵莹莹 1高锦 1胡丹1
作者信息
- 1. 100166 北京,联勤保障部队药品仪器监督检验总站
- 折叠
摘要
目的 建立碘佛醇注射液中乙二胺四醋酸二钠钙含量的测定方法.方法 采用高效液相色谱法测定碘佛醇注射液中乙二胺四醋酸二钠钙的含量,色谱柱为phenomenex Gemini® NX-C18 110Å(4.6 mm×25 cm,5 μm);等度洗脱;流动相为0.4%四丁基氢氧化铵(用磷酸调节pH至6.50)-乙腈(3∶1);检测波长:260 nm;流速:1 ml·min-1;柱温:40℃,进样体积:20 μl.结果 乙二胺四醋酸二钠钙在0.32～23.63 μg·ml-1 浓度范围内与峰面积线性关系良好(相关系数1.0000),平均回收率为99.12%,RSD为0.34%(n=6).结论 本方法简便,易于操作,准确性和重复性良好,可用于碘佛醇注射液中乙二胺四醋酸二钠钙的含量测定.
Abstract
Objective To establish a method for the determination of calcium disodium edetate in ioversol injection.Methods The content of calcium disodium edetate in ioversol injection was determined by HPLC.The phenomenex Gemini® NX-C18 110Å column(4.6 mm×25 cm,5 μm)was used with isocratic elution.The mobile phase was 0.4%tetrabutylammonium hydroxide solution(pH adjusted with phos-phoric acid to 6.50)-acetonitrile(3∶1).The detection wavelength was 260 nm.The flow rate was 1 ml·min-1.The column temperature was 40℃and the amount of injection was 20 μl.Results There was a good linear relationship between the concentration range of 0.32-23.63 μg·ml-1(r=1.0000)and peak area of calcium disodium edetate.The average recovery was 99.12%,with an RSD of 0.34%(n=6).Conclusion This method is simple,user-friendly,accurate and repeatable,which can be used for content determination of calcium disodium edetate in ioversol injection.
关键词
高效液相色谱法/碘佛醇注射液/乙二胺四醋酸二钠钙/含量测定Key words
high performance liquid chromatography/ioversol injection/calcium disodium edetate/content determination引用本文复制引用
出版年
2024
NETL
NSTL
万方数据