Impurity Profile Study of Tacrolimus Ointment Based on High Performance Liquid Chromatography-High Resolution Mass Spectrometry
OBJECTIVE To investigate the impurity profile of tacrolimus ointment and lay a foundation for the establishment of generic drug quality standard.METHODS HPLC-HRMS/MS was adopted to analyze the impurities in destroyed tacrolimus ointment.According to the primary and secondary mass spectrometry data combined with the mass spectrometry fragmentation pat-terns of impurities,the source and molecular structures of the impurities were speculated.RESULTS Tacrolimus ointment to-tally produced 10 impurities after destructive test,wherein contained three groups of isomers.CONCLUSION The analysis method of impurity profile established in this study provides a reference basis for the quality control and process optimization of ta-crolimus ointment.