厄贝沙坦杂质A的制备

目的: 建立厄贝沙坦杂质A的制备方法,进行结构解析并测定其含量。 方法: 以厄贝沙坦为原料,与碱反应后采用制备型高效液相色谱仪分离制备杂质A,并用IR、MS、¹H-NMR、¹³C-NMR等方法进行结构鉴定,用高效液相色谱法测定其含量。 结果: 杂质A的产率为40%,其含量为99.8%。 结论: 所建的制备方法简单,所得产物含量高,可用于厄贝沙坦杂质A对照品的制备。

Objective: To establish a method for irbesartan impurity A preparation,and analyze its structure and content. Methods: Irbesartan was used as the raw material and reacted with alkaline.Impurity A of irbesartan was then separated by prep-HPLC,and its structure was elucidated by IR,MS,¹H-NMR,and ¹³C-NMR;the content was determined by HPLC. Results: The yield of impurity A was 40%,and its content was 99.8%. Conclusion: The method is simple and convenient,which can be used to prepare the reference substance of impurity A.

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