Identification of a metal ion-induced degradation impurity in huperzine A injection / 中国药学杂志

ABSTRACT

OBJECTIVE: To identify the structure of an impurity of huperzine A injection. METHODS: HPLC-QTOF-MS was adopted to analyze the structure of the impurity, which was further isolated and prepared by prep-HPLC and the structure was established on the basis of spectroscopic data. RESULTS: The impurity was elucidated as (111E)-7,8-dichloro-5-amino-11-ethylidene-7-methyl-5,8,9,10-tetrahydro-5,9-methenecyclooctatriene [b] pyridin-2(1H)-one. CONCLUSION: The impurity was deduced as a metal ion-induced degradation product. This investigation provides reference for the improvement of quality control and process optimization of huperzine A injection.