离子色谱法同时测定硫酸妥布霉素注射液中硫酸根及抗氧剂焦亚硫酸钠的含量  

Simultaneous Determination of SO42-and Sodium Pyrosulfite in Tobramycin Sulfate Injection by Ion Chromatography

作　　者：范迪[1] 赵敬丹[1] 秦峰[1] 刘浩[1] FAN Di;ZHAO Jingdan;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所,上海201203

出　　处：《中国医药工业杂志》2020年第8期1056-1059,共4页Chinese Journal of Pharmaceuticals

摘　　要：建立了离子色谱法同时测定硫酸妥布霉素注射液中硫酸根及抗氧剂焦亚硫酸钠的含量。采用Dionex Ion Pac AS11-HC色谱柱,以氢氧化钾溶液为淋洗液进行梯度淋洗,流速为1.0 ml/min,抑制器电流186 mA,使用电导检测器检测,柱温35℃。结果显示,焦亚硫酸钠在0.3~2.7μg/ml内线性关系良好,定量限为63.6 ng/ml,平均回收率为93.1%(n=9)。硫酸根在10~400μg/ml内线性关系良好,定量限为0.33 ng/ml,平均回收率为97.0%(n=9)。本试验建立的方法准确、灵敏、重复性好,可为硫酸妥布霉素注射液中焦亚硫酸钠的用量控制以及硫酸根与焦亚硫酸钠的同时测定提供参考。In this study,an ion chromatography method was established for simultaneous determination of sulfate and antioxidant sodium pyrosulfite in tobramycin sulfate injection.A Dionex Ion Pac AS11-HC chromatographic column was used,and the potassium hydroxide solution was used as elution for gradient elution at the flow rate of 1.0 ml/min.The test was conducted by a conductivity detector with the inhibition current of 186 mA and the column temperature of 35℃.The results showed that it was linear for sodium pyrosulfite in the range of 0.3-2.7μg/ml,and the limit of quantification(LOQ)was 63.6 ng/ml.And for SO42-,it was linear in the range of 10-400μg/ml,and its LOQ was 0.33 ng/ml.Their average recoveries were 93.1%and 97.0%(n=9).This method was accurate,sensitive and reproducible,which could provide a reference for the control of the sodium pyrosulfite amount in tobramycin sulfate injection and the simultaneous determination of sulfate and sodium pyrosulfite.

关 键 词：离子色谱法 硫酸妥布霉素注射液 抗氧剂 焦亚硫酸钠 

分 类 号：O657.7[理学—分析化学]