Quality Study Of Cetilistat

Cetilistat is a new pancreatic lipase inhibitor used to treat obesity which was approved in September,2013 by PMDA of Japan.The greatest advantage of cetilistat is that it does not work on the nervous system,it does not affect the activity of other enzymes in the gastrointestinal tract,it is poorly absorbed,it could not be absorbed into the blood,does not decrease appetite and without the need to restrict the diet.Phase III trials are currently underway in the United States,moreover,this drug substance is not still marketed domestically,haven't been collected by pharmacopoeia until now.Therefore,cetilistat is worth developing and declaring with important sense.The chemical structure of Cetilistat were elucidated using UV-VIS,IR,NMR,ESI-MS,Elemental Analyzer,XRD,TGA,DSC.The purpose of this paper is concerned with the quality of cetilistat,including the character,identification,other test item,assay and the like,what's more,the methodology were carried out.The related substances method validation result showed that the HPLC established in this thesis has good specificity,LOD,LOQ,linearity,precision,solution stability and recovery.Because organic solvent were used in the synthesis process of cetilistat,this paper established a gas chromatographic method for the determination of residual solvents in cetilistat,method specificity,LOD,LOQ,linearity,precision and recovery were validated.The HPLC method was established for determining the content of cetilistat.Furthermore,stability study including the long-term stability,accelerate stability and stress test,were performed,as a result,the quality standard of cetilistat was verified.According to the appendix of Chinese Pharmacopoeia and relevant technical guiding principles,the specification of cetilistat was established based on the study result of this paper,while the explanation related to specification was also developed.