Academic Journals Database
Disseminating quality controlled scientific knowledge

Validation of chromatographic analysis

ADD TO MY LIST
 
Author(s): Onjia Antonije E. | Vasiljević Tatjana M. | Čokeša Đuro M. | Laušević Mila D.

Journal: Hemijska Industrija
ISSN 0367-598X

Volume: 56;
Issue: 2;
Start page: 76;
Date: 2002;
VIEW PDF   PDF DOWNLOAD PDF   Download PDF Original page

Keywords: validation | HPLC | precision | accuracy

ABSTRACT
The parameters for the development of a chromatographic (HPLC) method and its validation are discused in the paper. Chromatographic analysis involves a multi-step procedure consisting of sample collection, pretreatment instrumental measurements and data processing. Emphasize was placed on the instrumental part of the analysis presuming that the contributions of the other variables were minor. The roles of precision, accuracy, detection limit, quantification limit, specificity, selectivity, range, linearity and robustness, as well as system suitability in the analytical application of chromatography were described. Recommendations for the validation of these parameters according to ICH and FDA guidelines are given. The criteria of validation described above can be almost completely applied to other instrumental chromatographic techniques such as GC, GC-MS, HPTLC, etc.
Why do you need a reservation system?      Save time & money - Smart Internet Solutions