DAILY VALIDATION PROCEDURE OF CHROMATOGRAPHIC ASSAY USING GAUSSOEXPONENTIAL MODELING

High performance liquid chromatography is one of the most successful a nalytical methods used for the quantitative determination of drugs in biological samples. However, this method is marked by a lack of perfor mance reproducibility: chromatographic peaks become wider and even asy mmetrical as the column ages. These progressive changes in the chromat ographic parameters have to be taken into account when evaluating the validation criteria for the method. These criteria change with the age ing process of the column leading to the need for new estimations to a ssure the quality of the results. Procedures are proposed for the dail y determination of some validation criteria using the exponentially mo dified Gaussian (EMG) model of the chromatographic peak. This modellin g has been studied on simulated chromatographic peaks in order to obta in the relationships between chromatographic measurements and EMG para meters.