Development and validation of a new HPLC-MS method for meglumine impurity profiling.

摘要: Abstract We report a new High Performance Liquid Chromatography-Mass Spectrometry (HPLC–MS) method to rapidly detect and quantify meglumine by-products (specifically reducing sugar(s) nitrogen impurities) that could be present in the samples. Meglumine is secondary amine obtained from glucose it an excipient used as counter-ion several pharmaceutical formulations, especially when concentration of active ingredient (API) so high sodium not suitable option. Moreover, increased use related its ability improve solubility aqueous solutions due presence large number hydroxyl groups. Thus, even if widely impurity profile has never been fully evaluated. Here, we propose commercial agent specifically reacts with carbonyl compounds, 1-(4-aminobenzyl)-1,2,4-triazole, aim improving detection sugars, such glucose, after easy derivatization procedure. Finally, describe validation analysis samples different manufacturers.