CHARACTERIZATION OF TEPOXALIN AND ITS RELATED-COMPOUNDS BY HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY MASS-SPECTROMETRY

High-performance liquid chromatography/mass spectrometry (HPLC/MS) was used to identify and elucidate key structural characteristics of a no vel dual cyclooxygenase/lipoxygenase inhibitor, tepoxalin enyl)-3-pyra zolyl]-N-hydroxy-N-methylpropanamide), its synthesis-related byproduct s in bulk drug substance, and degradation products stemming from probe stability studies. Such information is needed to assist in synthesis optimization and in the preparation of stable formulations for toxicit y studies and clinical trials. High-performance liquid chromatography, in conjunction with mass spectrometry (HPLC/MS) and UV photodiode arr ay detection, can often expedite the gathering of preliminary data tha t contribute to several aspects of the pharmaceutical development proc ess.