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乙酰氨基阿维菌素国家对照品的研制
戴青,陆连寿,赵富华,张秀英
0
(中国兽医药品监察所)
摘要:
以乙酰氨基阿维菌素为原料研制首批乙酰氨基阿维菌素国家对照品,并进行质量评价。采用高效液相色谱法和质谱法对原料进行结构确证,分装后的乙酰氨基阿维菌素对照品采用质量平衡法定值,同时采用高效液相色谱外标法加以佐证。结果显示,以质量平衡法计算乙酰氨基阿维菌素(B1a+B1b)含量为97.79%,液相色谱外标法测定含量为98.18%,两种方法测定结果基本一致。本次研制的乙酰氨基阿维菌素对照品可用于乙酰氨基阿维菌素及其制剂的鉴别与含量测定。
关键词:  乙酰氨基阿维菌素  国家对照品  质量平衡法  高效液相色谱法
DOI:
投稿时间:2022-03-30修订日期:2022-04-25
基金项目:
Development of Eprinomectin as National Reference Standard
(China Institute of Veterinary Drug Control,Beijing,100081;China)
Abstract:
To develop the first batch of national reference standard of eprinomectin, eprinomectin was used as raw material and the quality inspection was tested. Eprinomectin material was identified by HPLC and MS. The content of eprinomectin reference standard packaged was valued by mass balance method and HPLC external standard method. The results show that, the content of eprinomectin was 97.79% by mass balance method and 98.18% by HPLC external standard method. The results of the two methods were basically consistent. The national reference of eprinomectin in this study can be used for the identification of the preparations of eprinomectin.
Key words:  eprinomectin  national reference standard  mass balance method  HPLC

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