کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
7627563 | 1494586 | 2018 | 15 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Development and validation of a new HPLC-MS method for meglumine impurity profiling
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کلمات کلیدی
موضوعات مرتبط
مهندسی و علوم پایه
شیمی
شیمی آنالیزی یا شیمی تجزیه
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چکیده انگلیسی
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.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 149, 5 February 2018, Pages 517-524
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 149, 5 February 2018, Pages 517-524
نویسندگان
C. Martano, F. Ferretti, S. Ghiani, F. Buonsanti, E. Bruno, L. Lattuada, C. Medana,