Contribution of Multivariate Analysis to the In Vitro Dissolution Profile for Testing Clopidogrel Drugs Similarity

A novel approach to test the similarity of clopidogrel batches by comparing drug dissolution profiles, based on the combination of principal component analysis with hierarchical cluster analysis (PCA-HCA), is presented. Dissolution curves corresponding to five brands of clopidogrel drugs, taken as model drugs, were prepared by measuring the dissolution rate in pH 1.2, 4.5, and 6.8). The dissolution data were analyzed by similarity factor ([f.sub.2]) calculation and the PCA-HCA method, and the results were compared. Unlike the [f.sub.2] test, the PCA-HCA approach reflects the variability inside the individual dissolution patterns, which it is also sensitive to profile variations (form and size). The comparison between the PCA-HCA results with those of [f.sub.2] tests gives approximately similar results, knowing that PCA-HCA represents, in general, a more discriminative criterion. KEYWORDS: Clopidogrel, dissolution, similarity, multivariate analysis