Naslov
Prevalidation in pharmaceutical analysis. Part I: Fundamentals and critical discussion

Autori
Grdinić, Vladimir ; Vuković, Jadranka

Izvornik
Journal of pharmaceutical and biomedical analysis (0731-7085) 35 (2004); 489-512

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
Prevalidation strategy; Standardization of analytical procedures; Quality control of laboratory methods; Performance testing; Experimental design; Method validation; Polyphenols; Folin-Ciocalteu’ s reagent

Sažetak
A complete prevalidation, as a basic prevalidation strategy for quality control and standardization of analytical procedure was inaugurated. Fast and simple, the prevalidation methodology based on mathematical/statistical evaluation of a reduced number of experiments (N Ł 24) was elaborated and guidelines as well as algorithms were given in detail. This strategy has been produced for the pharmaceutical applications and dedicated to the preliminary evaluation of analytical methods where linear calibration model, which is very often occurred in practice, could be the most appropriate to fit experimental data. The requirements presented in this paper should therefore help the analyst to design and perform the minimum number of prevalidation experiments needed to obtain all the required information to evaluate and demonstrate the reliability of its analytical procedure. In complete prevalidation process, characterization of analytical groups, checking of two limiting groups, testing of data homogeneity, establishment of analytical functions, recognition of outliers, evaluation of limiting values and extraction of prevalidation parameters were included. Moreover, system of diagnosis for particular prevalidation step was suggested. As an illustrative example for demonstration of feasibility of prevalidation methodology, among great number of analytical procedures, VIS-spectrophotometric procedure for determination of tannins with Folin-Ciocalteu's phenol reagent was selected. Favorable metrological characteristics of this analytical procedure, as prevalidation figures of merit, recognized the metrological procedure as a valuable concept in preliminary evaluation of quality of analytical procedures.

Izvorni jezik
Engleski

Znanstvena područja
Farmacija

POVEZANOST RADA