Studies For Saxagliptin Tablets

Saxagliptin,a new kind of dipeptidyl peptidase IV inhibitors,is a novel drug treating diabetes,its research is very important for patients,families and society.Saxagliptin tablets are the sixth sort of medicines.In this study,the formulation and preparation of the Saxagliptin tablets were determined,and then its quality and stability were investigated.In the research,we used an active coating technique in the preparation of saxagliptin tablets.First of all,we studyed the composition and preparation of blank core,the type of coated powder,the configuration of the drug-containincoating liquid,the number of coating layers,the conditions of preparation and other projects,and then the formulation and preparation of saxagliptin tablets were determined.In the research,we studied the quality of saxagliptin tablets and investigated its character.IR spectrophotometry,and High Performance Liquid Chromatography,were all established to identify them respectively.We also checked out its related substances,moisture,dissolution,determination and other projects.These results accorded with pharmacopoeia and related quality standards.A simple and efficient HPLC method was developed for quality control of the related substances.Waters C18 column was used with the mobile phase of A: water: acetonitrile: glacial acetic acid =90:10:0.05 and the mobile phase of B: water: methanol: glacial acetic acid =30:70:0.05,the ratio of mobile phase A and mobile phase B was 70: 30.Column temperature was 35℃,and the flow rate was 1.0 m L/min,at the detection wavelength of 220 nm and the injection volume was 20 μL.The dilution was 1%(v / v)hydrochloric acid solution.These results showed that the separation of saxagliptin peak and impurities peaks were more than 2.0,and blank solvent and excipients didn’t interfere the determination of related substances.linearity,specificity,precision,durability and high degree of accuracy were good in the test.Therefore,the method can be used to control the related substances of saxagliptin.Simple and efficient HPLC method was also developed for quality control of the dissolution.Agela C18 column was used with the mobile phase of water: acetonitrile: glacial acetic acid =80:20:0.03.Column temperature was 30℃,and the flow rate was 1.7 m L/min,at the detection wavelength of 220 nm and the injection volume of 50 μL.These results showed that blank excipients and media didn’t interfere the determination of saxagliptin.In four mediums,the Saxagliptin’s linearity was all good.The precision,accuracy,stability and the RSD of durability testing were less than 2.0%.Meanwhile,the chromatographic conditions of determination were the same as the related substances.These results showed that the method had good linearity,specificity,precision,durability and high degree of accuracy in the test.So the method can be used to control the determination of saxagliptin.Finally,the stability of saxagliptin tablets was investigated.These results showed that there was a same trend between self-made and commercial tablet on characters,dissolution,content and the related substances of the three batches of saxaglipt tablets.It was also consistent with the Chinese Pharmacopoeia and the related quality standards.The quality standards of the saxagliptin tablets were all scientific and reliable.