Method for the preparation of pure nilotinib and its salt

The present invention discloses a method for the preparation of pure nilotinib and its salt. The method comprises the following steps: (a) providing the solution of free alkali raw material of a chemical compound of the formula (I) in the mixture of C1-C4 alcohol and mineral acid; (b) adding alkali into the solution in the step (a) in order to acquire pH value of being more than 8, inoculating thesolution in the step (b); (c) inoculating the solution in the step (b) if appropriate; (d) acquiring a suspension solution of the chemical compound of the formula (I); (e) separating a product of theformula (I). The invention aims to the method to prepare pharmaceutical active ingredient Nilotinib free base or Nilotinib dihydrochloride dihydrate by means of an improved crystallization procedure. 本发明公开了制备纯的尼洛替尼及其盐的方法。所述方法包括下述步骤：(a)提供式(I)化合物的游离碱原材料在C-C醇与无机酸的混合物中的溶液：(b)向所述步骤(a)的溶液添加碱，以获得高于8的pH值：(c)任选地，接种所述步骤(b)的溶液；(d)获得式(I)化合物的悬液；(e)分离式(I)的产物。本发明的目的是种利用改进的结晶过程来制备药物活性成分尼洛替尼游离碱或尼洛替尼二盐酸盐二水合物的方法。