The Research Report Of Analytic Technology On The Impurities In Topiramate

Objective:Combined synthesis route,analysis topiramate possible impurities in raw materials,and for each impurity analysis method is established.Methods:Using ion-pair HPLC determination of sulfamate and sulphate,adopts HPLC determination of the impurities ??? and pyridine solvent residues and impurities,six volatile organic impurities were determined simultaneously by GC.Result:Sulfamate is concentrate within the range from 0.59 to 5.94?g/ml,and sulfate is 0.61?6.08?g/ml.They expressed a perfect linear relationship(r2? 0.9993).Their main numbers of recovery are 94.85%(RSD 4.48%,n=9)and 101.23%(RSD 1.17%,n=9.The correction factor of impurity I for topiramate is 0.75,the correction factor of impurity II for topiramate is 0.74.pyridine shows a great linear relatioship inside the concentratioin range of 0.39?2.34 ?g/ml,and its average recovery rate is 98.13%(RSD=0.57%,n=9).The degree of separation and detection sensitivity are comply with the requirements between methylbenzene and acetone?methylene dichloride?ethyl acetate?n-hexane?butylene oxide conclusion,HPLC and GC are able to quickly,simply,accurately and reliably test the impurities inside topiramate raw material.