کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1220112 1494604 2016 9 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Electrochemical oxidation coupled with liquid chromatography and mass spectrometry to study the oxidative stability of active pharmaceutical ingredients in solution: A comparison of off-line and on-line approaches
ترجمه فارسی عنوان
اکسیداسیون الکتروشیمیایی همراه با کروماتوگرافی مایع و اسپکترومتری جرمی برای مطالعه پایداری اکسیداتیو مواد تشکیل دهنده دارویی فعال در محلول: مقایسات روشهای آفلاین و خطی
کلمات کلیدی
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
چکیده انگلیسی


• Use of electrochemistry as a stress test condition.
• Development of a new dual pump automated electrochemical screening platform.
• Automated sequential analysis of large numbers of different solutions.

Stability studies of pharmaceutical drug products and pharmaceutical active substances are important to research and development in order to fully understand and maintain product quality and safety throughout its shelf-life. Oxidative forced degradation studies are among the different types of stability studies performed by the pharmaceutical industry in order to understand the intrinsic stability of drug molecules. We have been comparing the use of electrochemistry as an alternative oxidative forced degradation method to traditional forced degradation and accelerated stability studies. Using the electrochemical degradation approach the substrate oxidation takes place in a commercially available electrochemical cell and the effluent of the cell can be either a) directly infused into the mass spectrometer or b) injected in a chromatographic column for separation of the different products formed prior to the mass spectrometry analysis. To enable the study of large numbers of different experimental conditions and molecules we developed a new dual pump automated electrochemical screening platform. This system used a HPLC pump and autosampler to load and wash the electrochemical cell and deliver the oxidized sample plug to a second injection loop. This system enabled the automatic sequential analyses of large numbers of different solutions under varied experimental conditions without need for operator intervention during the run sequence. Here we describe the system and evaluate its performance using a test molecule with well characterized stability and compare results to those obtained using an off-line electrochemistry approach.

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ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 131, 30 November 2016, Pages 71–79
نویسندگان
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