Consistency Evaluation Of Dissolution Curves Between Generic And Branded Imatinib Mesylate Tablets In Various Media

Objective:To investigate the consistency of dissolution curves of generic and branded Imatinib mesylate tablets in various dissolution mediums.Methods:The paddle method was adopted with rotation speed of 50r/min,using pH 1.2 hydrochloric acid solution,p H 4.0 acetic acid-sodium acetate buffer solution,pH 6.8 phosphate buffer solution and water as dissolution media,volume of dissolution medium was 1000 mL.UV spectrometry was performed on the column of 264 nm to determine average accumulative dissolution of generic and branded Imatinib mesylate tablets at different time points to draw out dissolution curves,then to evaluate the similarity of dissolution curves.Results:In 4 dissolution media,the dissolution rate of generic and branded Imatinib mesylate tablets both were more than 85% within 15 min,which indicated that the dissolution curves had similarity.Conclusion : The dissolution profile of Imatinib mesylate tablet generic and branded preparations showed similarity.