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Process for preparing clomipramine salts
专利权人:
HERBERT BROWN PHARMACEUTICAL & RES LAB
发明人:
GUND VITTHAL GENBHAU,GUND VITTHAL GENBHAU,SHINGOTE SANTOSH SHIVAJI,SHINGOTE SANTOSH SHIVAJI,SHINDE RAHUL BABANRAO,SHINDE RAHUL BABANRAO,KULKARNI PRASAD RAMAKANT,KULKARNI PRASAD RAMAKANT
申请号:
IN1466/MUM/2013
公开号:
IN2013MU01466A
申请日:
2013.04.22
申请国别(地区):
IN
年份:
2015
代理人:
摘要:
The present invention relates to an improved process for the preparation of Clomipramine salts, particularly Clomipramine hydrochloride of Formula I and Clomipramine sulfate of Formula II. The process for the preparation of Clomipramine hydrochloride of Formula I comprises of reacting 3-chloroiminodibenzyl with N,N-dimethylaminopropyl chloride in an aromatic hydrocarbon in presence of an alkali metal hydroxide; filtering the reaction mixture, cooling, diluting with water and adding aqueous sulfuric acid to obtain crude Clomipramine sulfate; recrystallizing the crude Clomipramine sulfate using acetone-water mixture to obtain Clomipramine sulfate of Formula II having HPLC purity of more than 99.5%; suspending Clomipramine sulfate of Formula II in water, adding an aqueous alkali metal hydroxide solution and an aliphatic hydrocarbon, stirring and separating an aqueous layer and an organic layer; charcoalizing the organic layer, cooling and adjusting pH by addition of alcoholic hydrochloride to yield Clomipramine hydrochloride of Formula I having HPLC purity of more than 99.7%.
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