کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1245549 969725 2008 8 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Validation of a fluorimetric assay for 4-aminophenol in paracetamol formulations
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
Validation of a fluorimetric assay for 4-aminophenol in paracetamol formulations
چکیده انگلیسی

4-Aminophenol (4-AP) is the primary degradation product of paracetamol (PARA). According to the European Pharmacopoeia, 50 ppm 4-AP/PARA is the specification limit of 4-aminophenol in paracetamol drug substance. For drug products, often higher specification limits, such as 1000 ppm 4-AP/PARA are applied. This paper describes a fluorimetric method to quantify the low amount of this degradant (50 ppm) in a pharmaceutical preparation, i.e. in paracetamol tablets. The fluorimetric method was validated and the linearity, precision, trueness, range, limit of detection and limit of quantification were determined. They were found acceptable to assay the low amounts of 4-aminophenol in paracetamol tablets.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Talanta - Volume 75, Issue 1, 15 March 2008, Pages 258–265
نویسندگان
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