Study Of Dapoxetine Hydrochloride Tablets

ObjectiveThe purpose of this study is to explore and optimize the prescription and preparation method of dapoxetine hydrochloride tablets,and estabilish its quality standard.First,we plan to build a preparation method which is economic,environmental protectable,simple operated,high yield and suitable for industrial production.Second,we plan to establish methods for detecting the solubility and the related substances in dapoxetine hydrochloride tablets,thus to establish a quality standard of dapoxetine hydrochloride tablets.ContentThe research in this paper is divided into three parts.The first part is a prescription for dapoxetine hydrochloride and a process study.The second part is the study of the determination of dapoxetine hydrochloride.The third part is the study of the matter of the dapoxetine hydrochloride tablets.MethodsThe author first reviewed a large amount of literature and made reasonable design for dapoxetine hydrochloride tablets.By comparing with the reference preparation "Priligy",we investigated the complementary makings,prescription,dissolution,impurity behavior quality survey analysis,such as solubility,hygroscopicity,compatibility with material inspection,the mixing time parameter,step granulating,wet granule,powder direct tabletting,embellish disintegrating agent,lubricating agent dosage screening,coating prescription selection,the weight of the coating increase research,selecting packaging material,thus to determine the prescription and preparation technology.The author compared the oar and basket methods for determining in vitro drug release of dapoxetine hydrochloride tablets by studying the influences of parameters such as the different rotating speed,the pH of release medium,the surfactant amount on the drug dissolution of dapoxetine hydrochloride tablets.The author established a high performancec liquid chromatography method for detecting dapoxetine hydrochloride through the investigations of the detecting wavelength,sample amount,specificity,and solution stability,repeatability,recovery,membrane filter interference test and system suitability.Based on the determination of sample volume,specificity,linearity,repeatability,precision and stability of self-reflection RSD value was < 2%,material quality research,related impurity detection conditions were determined.The method of measuring weight difference,the quality standard of the auxiliary materials,the identification of the sample and the method of testing,determine the quality standard of dapoxetine hydrochloride tablets.ResultsThe formulation and preparation of the dapoxetine hydrochloride tablet are determined.The oar method is used for evaluating in vitro drug release behavior of dapoxetine hydrochloride tablets.The rotation speed was 50 rpm,pH1.0 hydrochloric acid solution was used as the release medium.A high performance liquid chromatography(HPLC)method was established for detecting dapoxetine hydrochloride.The quality standard of dapoxetine hydrochloride tablets was successfully established.ConclusionsThe quality of home-made tablets in vitro pharmaceutical research is basically consistent with the imported tablet "Priligy" and the quality standard conforms to the standards of State Pharmaceutical Administration of China.