HPLC and LC-MS/MS Investigations for Remogliflozin Etabonate Degradation Product Identification and Characterization

This study aimed to demonstrate methodologies for employing liquid chromatography and liquid chromatography-mass spectrometry to identify, elute, and elucidate the structures of Remogliflozin (RMG) degradation products without isolating them from reaction mixtures. A review of existing literature reveals the absence of a specific tandem mass spectrometric technique for characterizing Remogliflozin’s degradation products. According to the International Conference on Harmonization guideline, oxidative, thermal, photolytic, and acid-base hydrolysis stress tests were conducted on Remogliflozin etabonate. Two major degradation products were identified: one under acidic conditions and another under basic conditions. A C18 column was utilized to separate each degradation product using high-performance liquid chromatography in isocratic mode. The method was validated with a correlation coefficient of 0.9998 and other validation parameters by the guidelines specified by the International Conference on Harmonization. The tandem mass spectrometric analysis of the degradation products facilitated the establishment of their chemical structures. Virtual toxicity analysis suggested that one of the degradation products could be hepatotoxic.