title: Analysis of purity in 19 drug product tablets containing clopidogrel: 18 copies versus the original brand.
abstract: In this study, 18 copies of PLAVIX tablets containing clopidogrel hydrogensulfate were compared to the innovator drug product for uniformity of mass, impurity profile, content, dissolution properties and stability. In order to be able to separate the R-enantiomer of clopidogrel, an enantiospecific liquid chromatographic method was used to determine the impurities and to perform the assay. The paddle method was used for dissolution testing. Most of the copies were not similar compared to the original drug product: their amount of impurities was higher, the content of clopidogrel lower, the dissolution profiles different and after 3 months under stress conditions in the original packaging, the results for the samples and the reference were significantly different in most of the cases.
authors.affiliation: Laboratorium voor Farmaceutische Chemie en Analyse van Geneesmiddelen, Faculteit Farmaceutische Wetenschappen, Katholieke Universiteit Leuven, Van Evenstraat 4, B-3000 Leuven, Belgium.
authors.forename: Y
authors.initials: Y
authors.lastname: Gomez
authors.forename: E
authors.initials: E
authors.lastname: Adams
authors.forename: J
authors.initials: J
authors.lastname: Hoogmartens
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods; D000077144:Clopidogrel; D004340:Drug Contamination; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000737:chemistry; D013607:Tablets; D013988:Ticlopidine / Q000031:analogs & derivatives* / Q000032:analysis* / Q000737:chemistry
chemical_list: D004364:Pharmaceutical Preparations; D013607:Tablets; D000077144:Clopidogrel; D013988:Ticlopidine