کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1220408 1494613 2016 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
A new method to identify hydrolytic degradants in drug substances with UPLC-MS using 18O-labelled water
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
A new method to identify hydrolytic degradants in drug substances with UPLC-MS using 18O-labelled water
چکیده انگلیسی


• The hydrolytic degradation of fluticasone propionate, duloxetine and amlodipine was studied in this work using 18O-labelled water with UPLC-MS.
• The proposed method to study hydrolysis using 18O-labeled water led to a number of proposed structures of corresponding degradants.
• The advantage of using 18O labeling experiments is the extra information from knowing whether a water molecule is incorporated into a degradant or not, therefore enabling either confirmation or disproval of a proposed molecular structure.

Drug substances are susceptible to many different degradation pathways due to diverse nature of the molecule structures. Hydrolysis is one of the most common reactions seen for drug substances and drug products since water is ubiquitously present either as moisture or included in some formulations such as parenteral products. The hydrolytic degradation of fluticasone propionate, duloxetine and amlodipine was studied in this work using 18O-labelled water with UPLC-MS. The structural proposals of the degradants are based solely on the molecular mass of the degradants with enhanced certainty by corresponding results from 18O labeling experiments. The advantage of using 18O labeling experiments is the extra information from knowing whether a water molecule is incorporated into a degradant or not, therefore enabling either confirmation or rejection of a proposed molecular structure.

The structure of Amlodipine along with the proposed structures of its degradants.Figure optionsDownload as PowerPoint slide

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 122, 15 April 2016, Pages 9–15
نویسندگان
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