Uncovering deficiencies in mass balance using HPLC with chemiluminescence nitrogen-specific detection

摘要: The author describes using high performance liquid chromatography (HPLC) with chemiluminescence nitrogen-specific detection and amperometric to determine organic impurities in a tedisamil dihydrochloride drug substance. results obtained confirm the validity of method its ability clarify deficiencies mass balance during forced degradation. HPLC was acceptable as stability-indicating for routine stability testing substance dosage form. nitrogenspecific method, however, provided reliable, more-accurate that revealed markedly less deficiency balance.