Comparison of impurity profiles of Lipiblock® vs. Orlistat using HPLC and LC-MS/MS

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 lev...

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Detalles Bibliográficos
Autores principales: Wagner, Vilegas, Severi, Juliana A., Wessjohann, Ludger A., Schneider, Alex
Formato: Articulo
Lenguaje:Inglés
Publicado: 2012
Materias:
Farmacia
HPLC-MS/MS; HPLC-UV; orlistat
Medicamentos Genéricos
Acceso en línea:http://sedici.unlp.edu.ar/handle/10915/8434
http://www.latamjpharm.org/resumenes/31/1/LAJOP_31_1_1_14.pdf
Aporte de:
SEDICI (UNLP) de Universidad Nacional de La Plata
id I19-R120-10915-8434
record_format dspace
institution Universidad Nacional de La Plata
institution_str I-19
repository_str R-120
collection SEDICI (UNLP)
language Inglés
topic Farmacia
HPLC-MS/MS; HPLC-UV; orlistat
Medicamentos Genéricos
spellingShingle Farmacia
HPLC-MS/MS; HPLC-UV; orlistat
Medicamentos Genéricos
Wagner, Vilegas
Severi, Juliana A.
Wessjohann, Ludger A.
Schneider, Alex
Comparison of impurity profiles of Lipiblock® vs. Orlistat using HPLC and LC-MS/MS
topic_facet Farmacia
HPLC-MS/MS; HPLC-UV; orlistat
Medicamentos Genéricos
description 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.
format Articulo
Articulo
author Wagner, Vilegas
Severi, Juliana A.
Wessjohann, Ludger A.
Schneider, Alex
author_facet Wagner, Vilegas
Severi, Juliana A.
Wessjohann, Ludger A.
Schneider, Alex
author_sort Wagner, Vilegas
title Comparison of impurity profiles of Lipiblock® vs. Orlistat using HPLC and LC-MS/MS
title_short Comparison of impurity profiles of Lipiblock® vs. Orlistat using HPLC and LC-MS/MS
title_full Comparison of impurity profiles of Lipiblock® vs. Orlistat using HPLC and LC-MS/MS
title_fullStr Comparison of impurity profiles of Lipiblock® vs. Orlistat using HPLC and LC-MS/MS
title_full_unstemmed Comparison of impurity profiles of Lipiblock® vs. Orlistat using HPLC and LC-MS/MS
title_sort comparison of impurity profiles of lipiblock® vs. orlistat using hplc and lc-ms/ms
publishDate 2012
url http://sedici.unlp.edu.ar/handle/10915/8434
http://www.latamjpharm.org/resumenes/31/1/LAJOP_31_1_1_14.pdf
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