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甲苯咪唑国家对照品的研制
引用本文:马秋冉,杨星,彭文绣,于晓辉. 甲苯咪唑国家对照品的研制[J]. 中国兽药杂志, 2021, 55(7): 35-40
作者姓名:马秋冉  杨星  彭文绣  于晓辉
作者单位:中国兽医药品监察所,,,中国兽医药品监察所
摘    要:以精制后的甲苯咪唑为原料研制甲苯咪唑国家对照品,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...

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
收稿时间:2021-01-27
修稿时间:2021-04-06

Development of Mebendazole as National Reference
Affiliation:China Institute of Veterinary Drug Control,Beijing,100081;China,,,
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.
Keywords:Mebendazole   national reference   mass balance method   volumetric method   HPLC external standard method
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