![]() ConclusionsÄegradation of cetirizine in polyethylene glycol arose from the reaction between the drug and the reactive peroxide intermediates such as peroxyl radicals formed through oxidation of PEG. The finding was verified by spiking of cetirizine degradation sample with cetirizine N-oxide reference standard. Site of oxidation is proposed based on correlation of the results of forced degradation with ionization scheme of cetirizine. Oxidation process was investigated in order to model the degradation of cetirizine in PEG-containing formulation. The reaction mixture was purified, and the isolated material was analyzed by 1H NMR. Additionally, pure cetirizine was subjected to selective oxidization by hydrogen peroxide and sodium percarbonate. MethodsĬetirizine, formulated in PEG-containing matrix, was subjected to forced degradation conditions in the pH range from 3 to 10, and the product was analyzed by HPLC and LC-MS/MS. The goal of the study was to isolate and analyze a cetirizine degradation product, formed within a PEG-containing formulation and to elucidate the mechanism of oxidation of cetirizine.
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