HPLC法测定羟基地美硝唑有关物质

Determination of related substances for hydroxy dimetridazole by HPLC

目的 用高效液相色谱法测定羟基地美硝唑的有关物质.方法 采用十八烷基硅烷键合硅胶为填充剂,甲醇-水（20：80）为流动相;流速为1.0mL/mim测定波长为315nm.结果 该方法具有很好的专属性,在0.02～21.21μg/mL浓度范围内峰面积与浓度成良好的线性关系,定量限和检测限分别为0.4和0.2ng/mL.结论 该方法专属性强,操作简便,测定准确,适用于羟基地美硝唑对照品的有关物质测定.

Objective An HPLC method is developed for the determination of hydroxy dimetridazole. In this Method Octadecylsilane chemically bonded silica is adopted as extender and the mobile phase has the methanol- water ratio of 20/80. The flow rate is set as 1.0mL/min and detection wavelength is 315nm. Results The results indicate this method has good specificity, the calibration curve is linear in the range of 0.02-21.21μg/mL, and the limit of quantification and limit of detection are 0.4 and 0.2ng/mL respectively. Conclusion The method is simple, accurate and good specificity. It can be used for the determination of related substances for hydroxy dimetridazole.