-
J Pharm Biomed Anal · Nov 2010
Comparative StudyComparison of impurity profiles of Orlistat pharmaceutical products using HPLC tandem mass spectrometry.
- A Schneider and L A Wessjohann.
- IDrug GmbH, Berlin, Germany; Department of Bioorganic Chemistry, Leibniz Institute of Plant Biochemistry, Halle, Saale, Germany. schneider@idrug.de
- J Pharm Biomed Anal. 2010 Nov 2; 53 (3): 767-72.
AbstractHPLC-UV and MS/MS studies of impurity profiles of original (Xenical, F. Hoffmann-La Roche Ltd., Switzerland) and generic (Cobese, Ranbaxy Laboratories Limited, India, and Orsoten, KRKA, Russia) products were carried out. The drug and related impurities were extracted by dissolving commercial samples in ethanol. The generic formulations contained higher levels of impurities than the original product. Impurity profiles (HPLC-MS/MS) of the generic samples are similar among themselves, whilst different in comparison to the impurity profile of the original product. The number of detected impurities for generics (14 impurities in Cobese and 13 impurities in Orsoten) is higher than for the original product (3 impurities in Xenical). Based on these analyses the overall analytical quality follows the order Xenical (best)>Orsoten>Cobese.Copyright (c) 2010 Elsevier B.V. All rights reserved.
Notes
Knowledge, pearl, summary or comment to share?You can also include formatting, links, images and footnotes in your notes
- Simple formatting can be added to notes, such as
*italics*,_underline_or**bold**. - Superscript can be denoted by
<sup>text</sup>and subscript<sub>text</sub>. - Numbered or bulleted lists can be created using either numbered lines
1. 2. 3., hyphens-or asterisks*. - Links can be included with:
[my link to pubmed](http://pubmed.com) - Images can be included with:
 - For footnotes use
[^1](This is a footnote.)inline. - Or use an inline reference
[^1]to refer to a longer footnote elseweher in the document[^1]: This is a long footnote..