Impurity profile study of cloxacillin sodium for injection / 中国药学杂志

ABSTRACT

OBJECTIVE: To investigate the impurity profile of cloxacillin sodium for injection and study the source of major impurities. METHODS: The impurities in samples from seven manufacturers were profiled by an optimized reversed-phase HPLC method and a newly established normal-phase HPLC method. The major impurities were prepared by semi preparation technology and identified by LC-QTOF-MS, 1H-NMR and 13C-NMR. RESULTS: Two new impurities relating with the salt-forming reaction and the purification process respectively, and four other new impurities were all successfully identified in this study. CONCLUSION: The study is suitable for profiling the impurities in cloxacillin sodium for injection and is quite useful for enhancing the quality control.