1.Faculty of Pharmacy /Department of Pharmaceutical Chemistry Jamia Hamdard (Hamdard University) New Delhi, India
2.Department of Chemistry Govt. (Autonomous) Girls P.G. College of Excellence Sagar, India
Abstract
Piracetam was subjected to the hydrolytic, oxidative, thermal and photolytic stress, according to ICH guideline Q1A (R2). The drug depicted degradation only in basic conditions, while it was stable to other stress conditions (acidic, neutral hydrolysis, thermal and photolytic conditions). A total of one degradation product was formed, which were separated on a BEH column employing an isocratic UPLC method. The degradation product was isolated and characterizes using UPLC-MS/MS,
1H NMR and IR. Initially, a total mass fragmentation pathway of the drug was established with the help of UPLC-MS/TOF studies. Subsequently, the isolated degradation product was subjected to MS/TOF mass studies to achieve their accurate mass, fragment pattern. The MS results helped to ascribe tentative structures to degradation product, which were verified through
1H NMR and IR. Based on the results, a complete degradation pathway for the drug has been proposed.