HPLC法测定硫酸妥布霉素注射液中乙二胺四乙酸二钠的含量  

Determination of Edathamil Disodium in Tobramycin Sulfate Injection by HPLC

作　　者：范迪 赵敬丹 闻宏亮 秦峰 刘浩 FAN Di;ZHAO Jingdan;WEN Hongliang;QIN Feng;LIU Hao(Shanghai Institute for Food and Drug Control,Shanghai 201203)

机构地区：[1]上海市食品药品检验研究院,上海201203

出　　处：《中国医药工业杂志》2021年第11期1501-1503,共3页Chinese Journal of Pharmaceuticals

摘　　要：建立了HPLC法测定硫酸妥布霉素注射液中乙二胺四乙酸二钠(EDTA-2Na)的含量。色谱柱采用Kromisil C_(18)柱,流动相A为含四丁基氯化铵的乙酸盐缓冲液,B为乙腈∶流动相A(6∶4),梯度洗脱。柱温为35℃,检测波长为350 nm,进样量为25μl。结果显示,EDTA-2Na在1.01~50.32μg/ml内线性关系良好,定量限和检测限分别为0.4、0.08μg/ml。平均回收率(n=9)为99.9%,RSD为0.9%。建立的方法操作简便、快速、灵敏度高,可用于硫酸妥布霉素注射液中EDTA-2Na的质量控制。An HPLC method was established to determine the content of edathamil disodium(EDTA-2Na)in tobramycin sulfate injection.A Kromisil C_(18) column was used.The analysis was carried out in the gradient elution mode with acetate buffer containing tetrabutylammonium chloride as mobile phase A,and acetonitrile∶mobile phase A(6∶4)as mobile phase B.The column temperature was 35℃,the detection wavelength was 350 nm,and the injection volume was 25μl.The results showed that it was linear for the EDTA-2Na in the range of 1.01–50.32μg/ml,and the limit of quantification and detection limit were 0.4 and 0.08μg/ml,respectively.The average recovery rate(n=9)was 99.9%with the RSD of 0.9%.The established method was simple,rapid and sensitive,which could be used for the quality control of EDTA-2Na in tobramycin sulfate injection.

关 键 词：硫酸妥布霉素注射液 乙二胺四乙酸二钠 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]