کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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1170750 | 960689 | 2007 | 9 صفحه PDF | دانلود رایگان |
Validation of analytical procedures is important for their efficient and reliable application. The International Conference on Harmonisation (ICH), Food and Drug Administration (FDA) and pharmacopoeia guidelines achieved a great deal in harmonising the definitions of the required validation characteristics. It is well known that poor reproducibility limits the practical implementation of capillary electrophoresis (CE). A precision study on four different MEKC methods was performed with 11 samples, containing seven antibiotics, by two analysts, in few days, on two capillary electrophoresis instruments. Five pharmaceutical preparations and three animal feeds were used. Precision was statistically analysed using migration time, peak area and height of each compound, as well as electroosmotic front (EOF). In 25 of 31 cases, the reproducibility of peak area, peak height and migration time was good (<5%). In most cases the reproducibility of peak area was much better than the reproducibility of peak height. The worst reproducibility that we observed was 12.7% for peak height and 7.6% for peak area.
Journal: Analytica Chimica Acta - Volume 594, Issue 1, 26 June 2007, Pages 119–127