| Analysis of purity in 19 drug product tablets containing clopidogrel: 18 copies versus the original brand. | |
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MedLine Citation:
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PMID: 15013148 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Y Gomez; E Adams; J Hoogmartens |
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Publication Detail:
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Type: Comparative Study; Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Journal of pharmaceutical and biomedical analysis Volume: 34 ISSN: 0731-7085 ISO Abbreviation: J Pharm Biomed Anal Publication Date: 2004 Feb |
Date Detail:
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Created Date: 2004-03-11 Completed Date: 2004-10-06 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8309336 Medline TA: J Pharm Biomed Anal Country: England |
Other Details:
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Languages: eng Pagination: 341-8 Citation Subset: IM |
Affiliation:
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Laboratorium voor Farmaceutische Chemie en Analyse van Geneesmiddelen, Faculteit Farmaceutische Wetenschappen, Katholieke Universiteit Leuven, Van Evenstraat 4, B-3000 Leuven, Belgium. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Chromatography, High Pressure Liquid
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methods Drug Contamination* Pharmaceutical Preparations / analysis, chemistry Tablets Ticlopidine / analogs & derivatives*, analysis*, chemistry |
| Chemical | |
Reg. No./Substance:
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0/Pharmaceutical Preparations; 0/Tablets; 55142-85-3/Ticlopidine; 90055-48-4/clopidogrel |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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