Comparison of impurity profiles of Orlistat pharmaceutical products using HPLC tandem mass spectrometry.
HPLC-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.
Schneider
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IDrug GmbH, Berlin, Germany; Department of Bioorganic Chemistry, Leibniz Institute of Plant Biochemistry, Halle, Saale, Germany. schneider@idrug.de
Wessjohann
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LA
D019440:Anti-Obesity Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004340:Drug Contamination; D007783:Lactones / Q000032:analysis*; D000077403:Orlistat; D053719:Tandem Mass Spectrometry / Q000379:methods*
D019440:Anti-Obesity Agents; D007783:Lactones; D000077403:Orlistat