Comparison of Impurity Profiles of Lipiblock (R) vs. Orlistat using HPLC and LC-MS/MS
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Data
2012-02-01
Autores
Schneider, Alex
Wessjohann, Ludger A.
Severi, Juliana A. [UNESP]
Wagner, Vilegas [UNESP]
Título da Revista
ISSN da Revista
Título de Volume
Editor
Colegio Farmaceuticos Provincia de Buenos Aires
Resumo
Comparative HPLC-UV and LC-MS/MS studies of impurity profiles of a reference sample (Xenical (R), F. Hoffmann La Roche Ltd., Switzerland) vs. generic (Lipiblock (R), EMS Sigma Pharma, a generic drug) were carried out with ethanol extracts of commercial samples. The generic formulation contained higher levels of common impurities as well as a considerable number of impurities not found in the reference product. The detected impurity profile of Lipiblock (R) revealed that it most likely is based on fermentation. Since the effect of the impurities is unknown, at this point fully synthetic Xenical (R) appears to offer a better safety margin than Lipiblock (R) which, however, compares quite well to other generic formulations.
Descrição
Palavras-chave
Generics, HPLC-MS/MS, HPLC-UV, Orlistat
Como citar
Latin American Journal of Pharmacy. La Plata: Colegio Farmaceuticos Provincia de Buenos Aires, v. 31, n. 1, p. 91-96, 2012.