Development and validation of a new HPLC-MS method for meglumine impurity profiling
| Autor: | E. Bruno, F. Ferretti, Claudio Medana, S. Ghiani, Chiara Martano, L. Lattuada, F. Buonsanti |
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| Rok vydání: | 2017 |
| Předmět: |
Time Factors
Clinical Biochemistry Pharmaceutical Science Excipient 030226 pharmacology & pharmacy 01 natural sciences High-performance liquid chromatography Impurity profiling Mass Spectrometry Analytical Chemistry Excipients 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Meglumine Drug Discovery medicine HPLC-MS Pharmaceutical ingredients 3003 Drug Discovery3003 Pharmaceutical Science Spectroscopy Solubility Derivatization Chromatography High Pressure Liquid Active ingredient chemistry.chemical_classification Aqueous solution Chromatography 010401 analytical chemistry Triazoles 0104 chemical sciences Reducing sugar chemistry Drug Contamination medicine.drug |
| Zdroj: | Journal of pharmaceutical and biomedical analysis. 149 |
| ISSN: | 1873-264X |
| Popis: | 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) and nitrogen impurities) that could be present in the meglumine samples. Meglumine is a secondary amine obtained from glucose and it is an excipient used as counter-ion in several pharmaceutical formulations, especially when the concentration of the active pharmaceutical ingredient (API) is so high that the sodium is not a suitable option. Moreover, the increased use of meglumine is related to its ability to improve solubility in aqueous solutions due to the presence of a large number of hydroxyl groups. Thus, even if meglumine is widely used as excipient in pharmaceutical formulations, its impurity profile has never been fully evaluated. Here, we propose the use of a commercial agent that specifically reacts with carbonyl compounds, 1-(4-aminobenzyl)-1,2,4-triazole, with the aim of improving the detection of reducing sugars, such as glucose, after an easy derivatization procedure. Finally, we describe the method validation and the analysis of the impurity profile of meglumine samples from different manufacturers. |
| Databáze: | OpenAIRE |
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