Research On The Quality Standards For Levetiracetam

Levetiracetam is a new antiepileptic drug which is ramification of ketopyrrolidine. It can control the paroxysm of epilepsy effectually. It has a high therapeutic index, wide margin of safety and lower side-effects compare with that of others. It is the only wide spectrum antiepileptic drug which has the prevention of epilepsy reported at present. As an innovative antiepileptic drug with extensive clinical application, it has huge quantity demands in international markets. At present, the product of our country is at the stage of clinical experiment. It is admitted to entering the domestic market hopefully in recent years.Because no legal quality standards and analysis methods of levetiracetam can be provided in pharmacopoeias of every countries, this paper involves the comprehensive analysis methods and quality research on it by modern analysis technology according to approval requirements of new drug in our country. Including structure identification, quality control research and stability inspect, quality standard draft is formulated according to the study results.Chemistry structure are studied by the HRMS, FTIR, UV, ¹H-NMR, ¹³C-NMR, MS, DSC, TG, XRD, et al. The all results prove that the sample' molecule structure is conformity with that of levetiracetam structure.In the quality research, scientific experiments were established according to chemical structure characteristic and production-techniques of levetiracetam. The study was emphasized on character, indentification, tests and assay. Physics and chemistry constants such as appearance, solubility, melting point and specific rotation were tested. The sample was identificated by IR and HPLC method, and appearance of solution, chlorides, loss on drying, residue on ignition, heavy metals were tested. HPLC methods were established for determination of levetiracetam's content and related substances. R-antimer of levetiracetam was tested by chiral stationary phase HPLC method. Residual of organic solvents were tested by capillary GC method. The analysis methods were studied and validated according to the ICH guidance. The methods were proved to be accurate and reliable with high selectivity, sensitivity and reproducibility, and were suitable for the quality control of levetiracetam.The influence factors of stability of levetiracetam are inspected by influence factor test, accelerated test and long-term test. Science basis are provided for manufacture, packing, storage and transportion. At the same time, life of span of drug is determined by test results.The quality standards established by the research can reflect drug's production techniques and quality, which providing efficient analysis methods and extimation standards for production as well as quality control. This subject is the quality research part of new drug resister domestically, and it is the necessary important data of manufacturing approval number' application. At the same time, the standards formulated by this study can be used to control the quality of the product effectively. It is of great importance to the product that can make a beeline for entering the international and domestic market, and raising the economic and social benifit of enterprise rapidly.