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

dc.creatorWagner, Vilegas
dc.creatorSeveri, Juliana A.
dc.creatorWessjohann, Ludger A.
dc.creatorSchneider, Alex
dc.date2012
dc.date2012-03-29T03:00:00Z
dc.identifierhttp://sedici.unlp.edu.ar/handle/10915/8434
dc.identifierhttp://www.latamjpharm.org/resumenes/31/1/LAJOP_31_1_1_14.pdf
dc.descriptionComparative 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.
dc.descriptionColegio de Farmacéuticos de la Provincia de Buenos Aires
dc.formatapplication/pdf
dc.format91-96
dc.languageen
dc.relationLatin American Journal of Pharmacy
dc.relationvol. 31, no. 1
dc.subjectFarmacia
dc.titleComparison of impurity profiles of Lipiblock® vs. Orlistat using HPLC and LC-MS/MS
dc.typeArticulo
dc.typeArticulo


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