Comparison of impurity profiles of lipiblock® vs. orlistat using HPLC and LC-MS/MS

Nenhuma Miniatura disponível

Data

2012-04-30

Autores

Schneider, Alex
Wessjohann, Ludger A.
Severi, Juliana A. [UNESP]
Wagner, Vilegas [UNESP]

Título da Revista

ISSN da Revista

Título de Volume

Editor

Resumo

Comparative HPLC-UV and LC-MS/MS studies of impurity profiles of a reference sample (Xenical®, F. Hoffmann-La Roche Ltd., Switzerland) vs. generic (Lipiblock®, 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® revealed that it most likely is based on fermentation. Since the effect of the impurities is unknown, at this point fully synthetic Xenical® appears to offer a better safety margin than Lipiblock® which, however, compares quite well to other generic formulations.

Descrição

Palavras-chave

Generics, HPLC-MS/MS, HPLC-UV, Orlistat, cobese, generic drug, lipiblock, orsoten, rotipuran, suprapur, tetrahydrolipstatin, unclassified drug, controlled study, drug formulation, drug impurity, drug safety, drug structure, fermentation, high performance liquid chromatography, intermethod comparison, liquid chromatography, mass spectrometry

Como citar

Latin American Journal of Pharmacy, v. 31, n. 1, p. 91-96, 2012.

Coleções