کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
10553538 967830 2011 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Optimisation and validation of a fast HPLC method for the quantification of sulindac and its related impurities
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
Optimisation and validation of a fast HPLC method for the quantification of sulindac and its related impurities
چکیده انگلیسی
The European Pharmacopoeia describes a liquid chromatography (LC) method for the quantification of sulindac, using a quaternary mobile phase including chloroform and with a rather long run time. In the present study, a new method using a short sub-2 μm column, which can be used on a classical HPLC system, was developed. The new LC conditions (without chloroform) were optimised by means of a new methodology based on design of experiments in order to obtain an optimal separation. Four factors were studied: the duration of the initial isocratic step, the percentage of organic modifier at the beginning of the gradient, the percentage of organic modifier at the end of the gradient and the gradient time. The optimal condition allows the separation of sulindac and of its 3 related impurities in 6 min instead of 18 min. Finally, the method was successfully validated using an accuracy profile approach in order to demonstrate its ability to accurately quantify these compounds.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 54, Issue 4, 25 March 2011, Pages 694-700
نویسندگان
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