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《化学分析计量》 2022年第08期
DOI:10.3969/j.issn.1008-6145.2022.08.009
离子色谱-电化学法测定阿奇霉素中盐酸羟胺
徐艳梅,韩彬,郝丽娟,高燕霞,张素平
河北省药品医疗器械检验研究院,石家庄 050200 
Determination of hydroxylamine hydrochloride in azithromycin by ion chromatography-electrochemical method
XU Yanmei, HAN Bin, HAO Lijuan, GAO Yanxia, ZHANG Suping
Hebei Institute for Drug and Medical Device Control, Shijiazhuang 050200, China 
摘要:建立离子色谱-电化学法测定阿奇霉素中残留的盐酸羟胺。以IonPac CS1616阳离子交换柱(250 mm×4 建立离子色谱-电化学法测定阿奇霉素中残留的盐酸羟胺。以IonPac CS16阳离子交换柱(250 mm×4 mm)为分析柱,IonPac CG16阳离子交换柱(50 mm×4 mm)为保护柱;采用30 mmol/L甲磺酸溶液为淋洗液梯度洗脱,流量为0.8 mL/min;柱后中和试剂为500 mmol/L氢氧化钠溶液,流量为0.3 mL/min;采用电化学检测器进行检测,电极材料为金电极,参比电极为pH-Ag/AgCl复合电极;柱温为35℃;进样体积为25μL。盐酸羟胺的质量浓度在0.004 2~4.2μg/mL范围内与色谱峰面积线性关系良好(r=0.999 9)。盐酸羟胺的检出限和定量限分别为0.062 ng/mL和0.207 ng/mL,样品加标回收率为94.50%~100.46%,测定结果的相对标准偏差为1.9%(n=9)。该方法操作简单、专属性强、灵敏度高、重复性好,可用于阿奇霉素中痕量盐酸羟胺残留的检测。 
Abstract:An ion chromatography-electrochemical method for the determination of hydroxylamine hydrochloride residues in azithromycin was established. The method was carried out on IonPac CS1616 cation exchange analytical column (250 mm×4 mm) and IonPac CG16 cation exchange protective column (50 mm×4 mm); 30 mmol/L methanesulfonic acid solution was used as gradient elution with the flow rate of 0.8 mL/min, the post-column neutralization reagent was 500 mmol/L sodium hydroxide solution with the flow rate of 0.3 mL/min; the electrochemical detector was used for detection, the electrode material was gold electrode, and the reference electrode was pH-Ag/AgCl composite electrode; the column temperature was 35℃, and the injection volume was 25μL. The mass concentration of hydroxylamine hydrochloride had good linear relationship with the chromatographic peak area in the range of 0.004 2-4.2μg/mL (r=0.999 9). The detection limit and quantitation limit were 0.062 and 0.207 ng/mL, respectively. The average recovery rate of the sample standard addition was 94.50%-100.46% with the relative standard deviation of 1.87%(n=9). The method is simple, specific, sensitive and good reproducible, which can be used for the detection of trace hydroxylamine hydrochloride residues in azithromycin. 
关键词:离子色谱-电化学法;阿奇霉素;盐酸羟胺 
Keywords:ion chromatography-electrochemical; azithromycin; hydroxylamine hydrochloride 
本文引用格式:
徐艳梅,韩彬,郝丽娟,等.离子色谱-电化学法测定阿奇霉素中盐酸羟胺[J].化学分析计量,2022,31(8):39.
XU Yanmei,HAN Bin,HAO Lijuan,et al. Determination of hydroxylamine hydrochloride in azithromycin by ion chromatography-electrochemical method[J]. Chemical Analysis and Meterage,2022,31(8):39. 

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