Key words: impurities in pharmaceuticals, generics, GC-MS, derivatization, supercritical fluid extraction, liquid extraction, atmospheric pressure photochemical ionization mass-spectrometry
The possibility of comparison of original pharmaceuticals and their generics, based on multidimensional profiles of impurities isolated from different samples by supercritical fluid extraction and liquid extraction and registered by gas-chromatography/mass-spectrometry with electron ionization (EI) and atmospheric pressure photochemical ionization (APPCI) is investigated. The utilization of the suggested approach allows one to increase of the number of registered impurities and, thus, to identify the authenticity of pharmaceutical samples and to compare the quality of original pharmaceuticals and their generics.
doi:10.1134/S1990793111080094