HPLC法测定硝唑尼特中的3种有关物质  

Determination of Three Related Substances in Nitazoxanide by HPLC

作　　者：谢宜名[1] 张燕[2] 杨钊[2] 李新荣[2] 楚敏[2] 

机构地区：[1]青岛大学医学院药学系,山东青岛266021 [2]青岛市药品检验所

出　　处：《中国药师》2012年第5期680-682,共3页China Pharmacist

摘　　要：目的:建立HPLC法测定药物硝唑尼特中三种有关物质的方法。方法:色谱柱:Alltima C_8(250 mm×4.6 mm,5μm);流动相为乙腈-水(磷酸调节pH至2.5)梯度洗脱;流速:1.0 ml·min^(-1);柱温:25℃;检测波长210 nm。结果:硝唑尼特三种有关物质定量限分别为0.087 6,0.050 4,0.013 5μg·ml^(-1),硝唑尼特峰的理论塔板数大于7 000,且与杂质峰的分离度大于1.5。结论:本方法专属性强、灵敏度高、准确性高,适宜分析硝唑尼特中的有关物质。Objective：To establish an HPLC method for the determination of three related substances in nitazoxanide.Method： The separation was performed on an Alltima C_8（250 mm×4.6 mm,5μm）column with the mobile phase of acetonitrile-water（adjusting pH to 2.5 with phosphoric acid） with gradient elution at a flow rate of 1.0 ml ？ min^（-1）.The column temperature was 25℃and the detection wavelength was 210 nm.Result：The quantification limit of the three related substances in nitazoxanide was 0.087 6, 0.050 4 and 0.013 5μg ？ ml^（-1）,respectively.The theoretical plate number was above 7 000 with the resolution of the impurities over 1.5.Conclusion：The method is specific,sensitive and accurate,which can be used in the determination of related substances in nitazoxanide.

关 键 词：硝唑尼特 有关物质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]