Validation of chromatographic analysis

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.

U radu su razmatrani parametri za razvoj i validaciju hromatografske analitičke metode. Opisana je uloga preciznosti, tačnosti, granice detekcije, granice kvantifikativnog određivanja, specifičnosti, opsega linearnosti i robustnosti, kao i pogodnosti sistema u analitičkoj primeni hromatografije. Date su preporuke za ove parametre u skladu sa ICH i FDA regulativom.