Preparation method of high-purity nilotinib

一种高纯度尼罗替尼的制备方法

Abstract

本发明公开了一种高纯度尼罗替尼的制备方法,它包括尼罗替尼的合成与纯化两个步骤,其中纯化步骤又包括萃取、硅胶柱层析、二次萃取和重结晶等步骤。本发明制备的尼罗替尼纯度大于99.5%,单个杂质含量小于0.1%,产率达65%以上,工艺适合原料药级别的工业化生产。
The invention discloses a preparation method of high-purity nilotinib. The method includes two steps of synthesizing and purifying nilotinib. The purification further includes extraction, silica gel column chromatography, secondary extraction, re-crystallization, etc. The nilotinib is more than 99.5% in purity, is less than 0.1% in content of single impurity and is more than 65% in yield. The preparation method is suitable for industrial production in the scale of active pharmaceutical ingredients.

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