潘波 刘丽娟 陈玉双 郑玉林

    摘 要 目的：建立替硝唑原料药中杂质亚硝酸根的测定方法。方法：采用离子色谱法测定，Dionex IonPac AS19，3.5 mm×250 mm色谱柱，KOH溶液梯度洗脱。结果：亚硝酸根与替硝唑可达到基线分离。亚硝酸根在0.025～1.000 mg/ml范围内线性关系良好，检测限(LOD)为0.010 mg/ml，定量限(LOQ)为0.025 mg/ml。结论：该法操作简便，重现性好，结果准确可靠，可以用于替硝唑原料药中基因毒性杂质亚硝酸根的测定。

    关键词 替硝唑 亚硝酸根 离子色谱法

    中图分类号：R978.19； R917 文献标志码：A 文章编号：1006-1533(2021)11-0078-03

    Determination of impurity nitrite in tinidazole by ion chromatography

    PAN Bo1*， LIU Lijuan2， CHEN Yushuang2， ZHENG Yulin2**

    (1. Shanghai Sinopharm Holding Co.， Ltd.， Shanghai 200023， China； 2. Shanghai Fenglin Biological Technology Co.， Ltd.， Shanghai 201210， China)

    ABSTRACT Objective： To establish a method for the determination of nitrite in tinidazole bulk drug. Methods： The ion chromatography (IC) was carried out on a Dionex IonPac AS19 column with KOH solution as gradient elution. Results： Nitrite could be completely separated from tinidazole and its stranded curve showed good linearization over the range of 0.025-1.000 mg/ml with detection limit 0.010 mg/ml and quantitation limit 0.025 mg/ml. Conclusion： This method is simple ......