Validation of chromatographic analysis
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 instru...
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Association of Chemical Engineers of Serbia
2002-01-01
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Online Access: | http://www.doiserbia.nb.rs/img/doi/0367-598X/2002/0367-598X0202076O.pdf |
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doaj-4db76cc5ff064c59a4a4355b2b4b35282020-11-24T22:08:34ZengAssociation of Chemical Engineers of SerbiaHemijska Industrija 0367-598X2002-01-01562767910.2298/HEMIND0202076OValidation of chromatographic analysisOnjia Antonije E.Vasiljević Tatjana M.Čokeša Đuro M.Laušević Mila D.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. http://www.doiserbia.nb.rs/img/doi/0367-598X/2002/0367-598X0202076O.pdfvalidationHPLCprecisionaccuracy |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Onjia Antonije E. Vasiljević Tatjana M. Čokeša Đuro M. Laušević Mila D. |
spellingShingle |
Onjia Antonije E. Vasiljević Tatjana M. Čokeša Đuro M. Laušević Mila D. Validation of chromatographic analysis Hemijska Industrija validation HPLC precision accuracy |
author_facet |
Onjia Antonije E. Vasiljević Tatjana M. Čokeša Đuro M. Laušević Mila D. |
author_sort |
Onjia Antonije E. |
title |
Validation of chromatographic analysis |
title_short |
Validation of chromatographic analysis |
title_full |
Validation of chromatographic analysis |
title_fullStr |
Validation of chromatographic analysis |
title_full_unstemmed |
Validation of chromatographic analysis |
title_sort |
validation of chromatographic analysis |
publisher |
Association of Chemical Engineers of Serbia |
series |
Hemijska Industrija |
issn |
0367-598X |
publishDate |
2002-01-01 |
description |
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. |
topic |
validation HPLC precision accuracy |
url |
http://www.doiserbia.nb.rs/img/doi/0367-598X/2002/0367-598X0202076O.pdf |
work_keys_str_mv |
AT onjiaantonijee validationofchromatographicanalysis AT vasiljevictatjanam validationofchromatographicanalysis AT cokesađurom validationofchromatographicanalysis AT lausevicmilad validationofchromatographicanalysis |
_version_ |
1725815901571252224 |