Daily validation procedure of chromatographic assay using gaussoexponential modelling.
High performance liquid chromatography is one of the most successful analytical methods used for the quantitative determination of drugs in biological samples. However, this method is marked by a lack of performance reproducibility: chromatographic peaks become wider and even asymmetrical as the column ages. These progressive changes in the chromatographic parameters have to be taken into account when evaluating the validation criteria for the method. These criteria change with the ageing process of the column leading to the need for new estimations to assure the quality of the results. Procedures are proposed for the daily determination of some validation criteria using the exponentially modified Gaussian (EMG) model of the chromatographic peak. This modelling has been studied on simulated chromatographic peaks in order to obtain the relationships between chromatographic measurements and EMG parameters.
Tamisier-Karolak
S L
SL
Laboratoire de Chimie Analytique et d'Electrochimie Organiques, Faculté de Pharmacie, Chátenay-Malabry, France.
Tod
M
M
Bonnardel
P
P
Czok
M
M
Cardot
P
P
D002851:Chromatography, High Pressure Liquid / Q000592:standards*; D006863:Hydrogen-Ion Concentration; D007202:Indicators and Reagents; D016018:Least-Squares Analysis; D015233:Models, Statistical; D008962:Models, Theoretical; D011786:Quality Control; D015203:Reproducibility of Results
D007202:Indicators and Reagents