高效液相色谱法测定盐酸纳美芬注射液中的依地酸二钠含量  

Determination of disodium edetate in nalmefene hydrochloride injection by HPLC

作　　者：姚文静[1,2] 李琬晴 孙建绪[1] 郑爱萍[1] 

机构地区：[1]军事医学科学院毒物药物研究所药物制剂研究室,抗毒药物与毒理学国家重点实验室,北京100850 [2]北京华素制药股份有限公司,北京100070 [3]北京中医药大学基础医学院,北京100029

出　　处：《国际药学研究杂志》2017年第1期70-73,共4页Journal of International Pharmaceutical Research

摘　　要：目的建立盐酸纳美芬注射液中依地酸二钠的含量测定方法。方法采用高效液相色谱法测定。色谱柱:十八烷基硅烷键合硅胶柱;流动相:0.3%四丁基氢氧化铵溶液(盐酸调节p H至4.0)-水-乙腈(20∶45∶35,V/V/V);流速:1.0 ml/min;检测波长:254 nm;柱温:30℃;进样体积:20μl。结果依地酸二钠的定量限为0.199μg/ml,最低检测限为0.060μg/ml,在2.4593~7.3780μg/ml浓度范围内线性良好,线性方程为Y=10.125X-0.216,相关系数r=1.000,各浓度平均回收率在98%~102%之间,RSD%为0.58%。结论该检测方法专属性良好、简便,快速,灵敏,精密度高,重现性好。Objective To establish a high performance liquid chromatography（HPLC）method for the determination of disodium edetate（EDTA-2Na）in nalmefene hydrochloride injection. Methods Content of EDTA-2Na in nalmefene hydrochloride injection was determined by HPLC. C18 Column was used. The mobile phase consisted of 0.3% tetrabutylammonium hydroxide solution-wateracetonitrile（20∶45∶35）with a flow rate of 1.0 ml/min,and the detection wavelength was 254 nm. The column temperature was 30℃and the injection volume was 20 μl. Results The quantification limit and detection limit were 0.199 and 0.060 μg/ml,respectively;the linear equation for the disodium edetate was Y=10.125X-0.216,and the calibration curves were linear within the range of 2.4593~7.3780 μg/ml（r=1.000）. Each concentration of the average recovery was between 98~102%（n=9）（RSD%=0.58%）. Conclusion The method can be used for the determination of EDTA-2Na in nalmefene hydrochloride injection,which is convenient,fast,sensitive and reproducible,with good precision,specificity and accuracy.

关 键 词：高效液相色谱法 盐酸纳美芬 依地酸二钠 

分 类 号：R927.2[医药卫生—药学] O657.72[理学—分析化学]