甲苯咪唑国家对照品的研制

Development of Mebendazole as National Reference

关键词:  甲苯咪唑  国家对照品  质量平衡法  容量法  高效液相色谱法

Key words:  Mebendazole  national reference  mass balance method  volumetric method  HPLC external standard method

摘要:

为了研制甲苯咪唑国家对照品,采用精制后的甲苯咪唑为原料,并进行质量评价。采用紫外分光光度法、红外分光光度法对原料进行鉴别,采用质量平衡法定值,同时采用容量法和高效液相色谱法加以佐证。结果显示,紫外吸收图谱与标准规定一致、红外光吸收图谱与USP溯源对照品图谱一致；以质量平衡法计算其含量为99.8%,容量法测定含量为99.9%,液相色谱外标法测定含量为99.9%,三种方法测定结果一致。本次研制的甲苯咪唑对照品可用于甲苯咪唑及其制剂的鉴别与含量测定。

Abstract:

To develop the national reference of mebendazole. The refined mebendazole was used as raw material and the quality inspection was tested. The raw materials were identify by ultraviolet spectrophotometry and infrared spectrophotometry. The content of mabendazole was determine by the mass balance method, volumetric method and HPLC external standard method. The result show that , the UV spectrum was in accordance with the regulations, the IR spectrum was consistent with the USP traceable reference. The content of mebendazole was 99.8% by mass balance method, was 99.9% by volumetric method and was 99.9% by HPLC external standard method. The three determined contents were in accordance with each other. The national reference of mebendazole in this study can be used for the identification of the preparations of mebendazole.