氯硝柳胺中有关物质检查方法的研究

Detection of related substances in niclosamide

目的建立氯硝柳胺中有关物质的检测方法。方法采用高效液相色谱法(HPLC):Diamonsil(C18柱4.6×250mm,5μm),乙腈:缓冲液(每1000ml中含磷酸二氢钾2g,磷酸氢二钠1g,四正丁基硫酸氢铵2g)=3∶2为流动相,流速为1ml/min,检测波长为230nm,柱温为室温。结果本法可检出氯硝柳胺中主要杂质2-氯-4-硝基苯胺及5-氯水杨酸,并能检测出经强光照射、高温等破坏试验所产生的降解产物。结论本法简便、准确、灵敏度高,可用于氯硝柳胺中有关物质的检查方法。

Objective To establish a HPLC method for detection of related substances in niclosamide.Methods A HPLC method was established with Diamonsil C18 column.The mobile phase was acetonitrile：buffer solution（with monobasic potassium phosphate 2g,disodium hydrogen phosphate 1g and tetrabutylammonium hydrogensulfate 2g for per 1000ml） at 3：2,the flow rate was 1ml/min,and the detection wavelength was 230nm at RT.Results The related substances and its main degradation products can be detected by this HPLC method.Conclusions The method could be used for detection of the related substances in niclosamide