Development of a method for determining related impurities in a new biologically active compound of cardioprotective action by capillary electrophoresis

The original biologically active compound (BAS) N-[2-[4-oxo-3(4H)-quinazolinyl]propionyl]-guanidine (VMA-13-15), which has cardioprotective and neuroprotective activity, was synthesized on the basis of FSUE at VolgSMU Ministry Health Russian Federation. In accordance with XIV State Pharmacopoeia Federation, one criteria for quality control pharmaceutical substances is indicator "Related Impurities". Based synthesis scheme structure analyzed BAS as a technological impurity, we can assume presence initial - unsubstituted quinazoline-4(3H)-one, due to possible incomplete flow reaction. Objective: development validation evaluation methodology determining impurity (quinazoline-4(3H)-one) include it in draft regulatory document proposed VMA-13-15 substance. Materials methods. capillary electrophoretic conditions earlier by us determination under study were chosen analysis, compounds question are well separated clear peaks migration time 6.59 min 4.37 quinazoline-4(3H)-one. Results. As result this research, Impurities" using electrophoresis system developed. developed technique validated requirements SF RF edition proved be acceptable identified Conclusion. makes detect an content 0.1% or more.