ABSTRACT
OBJECTIVE: To establish a rapid and accurate high performance liquid chromatography/mass spectrometry method for the analysis of impurities in digoxin crude drug. METHODS: An HPLC-ESI-IT-TOF method was established. The fragmentation pathways of digoxin and digitoxin standards were studied. RESULTS: A total of 12 impurities were identified or tentatively characterized based on the fragmentation pathway. Digoxigenine-bisdigitoxoside-mono-glucose digoxigenin-tridigitoxosido-monoglucose were found for the first time in digoxin. CONCLUSION: It is extremely simple using HPLC-ESI-IT-TOF to provide chemical information concerning the constituents in Chinese herbal medicines, and it makes the identification results more convinced. The method has been applied for the international comparison study and given good results. Copyright 2012 by the Chinese Pharmaceutical Association.