کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1223612 967896 2007 8 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Validation of a dissolution method with HPLC analysis for lasofoxifene tartrate low dose tablets
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
Validation of a dissolution method with HPLC analysis for lasofoxifene tartrate low dose tablets
چکیده انگلیسی

A dissolution method with high performance liquid chromatography (HPLC) analysis was validated for an immediate release low dose tablet formulation. The method was validated to meet requirements for a global regulatory filing and this validation included specificity, precision, linearity, accuracy and range. Validation of precision included an intermediate precision study using an experimental design in order to satisfy Japanese regulatory requirements. In addition, filter suitability, standard and sample solution stability and method robustness were demonstrated. A statistical design of experiments was used for the robustness evaluation of both the dissolution method and the HPLC analysis method. All results were acceptable and confirmed that the method is suitable for its intended use.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 44, Issue 5, 3 September 2007, Pages 1064–1071
نویسندگان
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