Study On The Synthesis And Quality Of Duloxetine Hydrochloride

Duloxetine Hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration and has a better pharmacological profile for an antidepressant drug. Duloxetine is not only a highly efficient antidepressant agent for treating psychiatric disorders, but also can be used for treating other symptoms such as urinary incontinence, diabetic peripheral neuropathic pain and fibromyalgia. Duloxetine has some features such as improved efficacy, tolerability, safety, faster recovery, fewer side effects than other antidepressant in the clinical investigations.On the basis of the investigation about the synthetic methods of duloxetine which is a promising chiral medicine, an economical and reasonable synthetic route was studied. The target compound was obtained through resolution by S-(+)-mandelic acid and six steps. The starting materials include 2-acetylthiophene, paraformaldehyde and concentrated and low cost process for the synthesis of duloxetine hydrochloride is attained.The structural establishment is made for the compound with the methods of MS,UV,IR,NMR and its structure is conformed.In the article, Duloxetine's quality standard is basically determined after careful research on the relative material limit, organic volatile impurities and effective ingredient contents. The stability research has also been performed under high temperature circumstances, high wet circumstances and highlight circumstances respectively. Conclusions have been drawn out that at cool circumstances, the quality is stable, so duloxetine preserve in well-closed containers, protected from light. Store at room temperature.Duloxetine enteric-coated tablets' quality standard is basically determined after careful research on the realease as the UC. This article has established a HPLC method for determination of duloxetine hydrochloride tablets and its related substances.The brief synthesis route is low-contamination and feasible. A comparatively rounded study whose methods are classical is carried out for the quality of drug substance and its preparation. This quality critetion can be used to control and evaluate duloxetine and its tablets' quality.