高效液相色谱法测定盐酸吉西他滨脂质体中依地酸钙钠的含量  

Determination of Calcium Disodium Edetate in Gemcitabine Hydrochloride Liposomes by HPLC

作　　者：姚玲 顾晓风 YAO Ling;GU Xiao-feng(Suzhou Institute for Drug Control,Suzhou 215104,China)

机构地区：[1]苏州市药品检验检测研究中心,苏州215104

出　　处：《中国合理用药探索》2022年第5期102-107,共6页Chinese Journal of Rational Drug Use

摘　　要：目的:建立盐酸吉西他滨脂质体中依地酸钙钠含量测定的方法。方法:采用高效液相色谱法(HPLC)测定盐酸吉西他滨脂质体中依地酸钙钠的质量浓度,色谱柱为Capcell PAK C18(250mm×4.6mm,5μm);梯度洗脱,流动相A为0.33%硫酸铵溶液(用稀硫酸调至pH3.0),流动相B为乙腈;柱温35℃;检测波长254nm;流速1.0ml/min;进样量20μl。结果:依地酸钙钠在0.8~40.8μg/ml浓度范围内与峰面积线性关系良好(r=0.9999),平均回收率为99.83%,相对标准偏差(RSD)为0.41%(n=9)。结论:本方法简单准确,重复性好,可用于盐酸吉西他滨脂质体中依地酸钙钠的含量测定。Objective:To establish an HPLC method for determination of calcium disodium edetate content in gemcitabine hydrochloride liposomes.Methods:The content of calcium disodium edetate in gemcitabine hydrochloride liposomes was determined by HPLC,Capcell PAK C18(250 mm×4.6 mm,5μm)was used with gradient elution.Mobile phase A was 0.33%ammonium sulfate solution(adjust pH with dilute sulfuric acid to 3.0)and mobile phase B was acetonitrile.The column temperature was 35℃.The detection wavelength was 254 nm.The flow rate was 1.0 ml/min and the amount of injection was 20μl.Results:There is a good linear relationship between concentration and calibration curve of calcium disodium edetate in the range of 0.8~40.8μg/ml(r=0.9999),the average recovery was 99.83%,with RSD of 0.41%(n=9).Conclusion:The method is simple,accurate and repeatable,which can be used for the control of calcium disodium edetate in gemcitabine hydrochloride liposomes.

关 键 词：高效液相色谱法 盐酸吉西他滨 脂质体 依地酸钙钠 含量测定 

分 类 号：R927.2[医药卫生—药学]