摘要 |
A process for the preparation of paroxetine hydrochloride in which a suspension of paroxetine maleate is treated with an excess of hydrogen chloride to form a solution containing paroxetine, maleic acid, and hydrochloric acid, and crystallising substantially pure paroxetine hydrochloride from the solution. In this process paroxetine maleate in solution is directly converted to solid paroxetine hydrochloride, avoiding formation of paroxetine free base and subsequent re-acidifying with hydrogen chloride. The process surprisingly results in good yield and purity without the complication of large amounts of maleic acid contamination, and so is suitable for large-scale manufacture.
|