Study On Synthesis And Preparation Technology Of Dapoxetine Hydrochloride

Dapoxetine Hydrochloride is a selective serotonin reuptake inhibitor(SSRIs),the only drug currently approved for the treatment of male premature ejaculation.The first by the U.S.pharmaceutical company Elililly developed for the treatment of depression,and later by the Johnson company in Finland and Sweden as a drug approved for treatment of premature ejaculation.In this paper,it study the synthesis process of dapoxetine hydrochloride,and optimizes the synthetic route of dapoxetine with relatively cheap of benzaldehyde and malonic acid as the initial raw materials.synthesis technology has the advantages of simple route,easy operation,low cost,suitable for industrialization production.The quality standard of dapoxetine hydrochloride was studied,and the high performance liquid chromatography method was established for the determination of the content and related substances.The method is accurate,sensitive and convenient.The quality evaluation of three batches of self-made samples was carried out,all of which meet the standard requirements.Preparation and evaluation of Dapoxetine Hydrochloride Tablet,firstly,a method was established for the determination of dissolution of Dapoxetine Hydrochloride Tablet.Secondly,Study the preparation process and the stability of the preparation process,we also screened the prescription of the Dapoxetine Hydrochloride Tablet.Finally,the dissolution of the Dapoxetine Hydrochloride tablets was evaluated,we can draw a conclusion that the dissolution behavior of self-made samples are similar to original development medicines.We can make a preliminary estimate that the two drugs have bioequivalence.