AN IMPROVED PROCESS FOR PREPARATION OF CRYSTALLINE FORM-I OF PANTOPRAZOLE SODIUM SESQUIHYDRATE

摘要

The present invention relates to an improved process for the preparation of crystalline Form-I of Pantoprazole sodium sesquihydrate, chemically known as 5-(Difluoromethoxy)-2-[[C3,4-dimethoxy-2-pyridinyl) methyl] sulfinyl]-lH-benzimidazo!e sodium sesquihydrate. The Pantoprazole sodium sesquihydrate of the present invention can be depicted as Formula (1). The process for the preparation of crystalline Form-I of Pantoprazole sodium sesquihydrate comprises dissolution of Pantoprazole free base in which it substantially dissolves at an ambient temperature containing a stoechiometric quantity of sodium hydroxide, filtration of the clear solution and followed by addition of anti-solvent in which the product is insoluble to isolate the desired crystalline compound. The process of the present invention is cost effective and eco-friendly over prior art procedures.