Study On The Quality Of Febuxostat And Preparation

[Objective]On the basis of related literature and process research,the quality of febuxostat API and self-made tablets was studied.The original preparation was used as reference preparation,and the corresponding detection method was established to provide the basis for the formulation of internal control quality standard of febuxostat.[Methods]1.The quality of the self-made febuxostat API was studied and compared with the reference substance.2.The solubility of febuxostat and the dosage of sodium dodecyl sulfate(SDS)were investigated.The dissolution behavior of febuxostat self-made tablets and reference preparations in four dissolution media was compared by selecting dissolution medium and determining several dissolution curves with distinguishing power,and evaluated by f2 similarity factor method.4.Develop HPLC method to determine the content and content uniformity of tablets,and verify the methodology.[Results]The self-made raw materials were tested for moisture absorption,melting point determination,HPLC identification,drying weight loss,ignition residue and heavy metals.The results are in compliance with the pharmacopoeia regulations.According to the pH dependence of non buxostat,four dissolution mediums(pH6.0 phosphate buffer,water-0.3 SDS%solution,pH4.5 acetate buffer-0.5 SDS%,ph1.2 hydrochloride solution-0.7%SDS)were determined.The dissolution uniformity of self-made tablets met the requirements,and the methodological verification was qualified,The dissolution curve F2 values of self-made febuxostat tablets and reference preparation in four dissolution media were greater than 50,indicating that the dissolution behavior of self-made tablets and reference preparation in vitro was similar.The research object of impurities was determined,and the chromatographic conditions were developed and optimized to achieve good separation of impurities.It shows that the method has good specificity,the amount of impurities determined meets the limit requirements,and the methodological verification is qualified.According to the linear experiment,the relative correction factors of impurities were calculated.The method of content determination was established.The content determination and content uniformity of self-made tablet and reference preparation were all in accordance with the regulations,and the content determination methodology was verified to be qualified.[Conc lusion]The results showed that the formulation of the self-made tablet was scientific,the preparation process was stable and feasible,the quality was controllable,and it had similar characteristics with the reference preparation.