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 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.

Keywords

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