Quality Research And Stability Research Of Ropinirole Hydrochloride Extended-release Tablets

Ropinirole hydrochloride extended-release tablets was developed by GLAXOSMITHKLINE LLC and was approved by FDA on June,2008.This product is used in treatingParkinson's disease,once a day.It is very convenient for patients to use comparing to immediate release tablets and significantly improving treatment compliance.Only the import drugs were available on domestic market at present,in addition,Parkinson's disease will increase with the aging of population,so Huaihai pharmaceutical Inc.decided to develop the Ropinirole hydrochloride extended-release tablets.The analytical methods of identification,assay,dissolution and related substance were developed and validated according to ropinirole chemical structure and physicochemical character and literature.Results were revealed that these methods are specific,sensitive,accurate,precise.In the stability study,through accelerated test and long-term test,which can provide a scientific basis for the product production,package,storage and transportion,as well as preliminarily determine the period of validity.This study established a good foundation for the development of Ropinirole hydrochloride extended-release tablets and promoted the availability process of low price and high quality generic product for Parkinson's disease.