title: Quantification of omeprazole degradation by enteric coating polymers: an UV-VIS spectroscopy study.
abstract: The aim of this study was to investigate the degradation of the acid-labile proton-pump-inhibitor omeprazole in organic polymer solutions and aqueous dispersions of enteric coating polymers by UV spectroscopy. Furthermore, data were compared with those obtained in a previous HPLC study. For comparative purposes the cationic Eudragit RS 100 and the monomeric acid acetic acid were included in this study. The discolorations of degraded omeprazole solutions were analysed by VIS spectroscopy. UV-VIS spectra were recorded after preparation of the solutions and after 180 min of storage. The change of absorption was calculated as the difference of the absorption values at 305 nm. Degradation of omeprazole depends on the amount of acidic groups in the polymer structure. This decomposition manifests itself in a shifting of the absorption maximum to lower wavelengths and a decrease of absorption intensity. UV-VIS spectroscopy was used to determine the extent of degradation induced by enteric polymers. A good correlation of these results with previous HPLC data was found when excluding UV absorbing polymers. Nevertheless, values obtained by UV-VIS spectroscopy were always lower than those obtained by HPLC. For evaluation of the discoloration of degraded omeprazole solutions, VIS spectroscopy is a simple and fast method.
authors.affiliation: Institute for Pharmacy, Pharmaceutical Technology, University of Leipzig, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Riedel
authors.forename: C S
authors.initials: CS
authors.lastname: Leopold
mesh_terms: D019342:Acetic Acid; D000180:Acrylic Resins; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D003116:Color; D004339:Drug Compounding; D004355:Drug Stability; D000431:Ethanol; D005079:Excipients; D009853:Omeprazole / Q000008:administration & dosage / Q000032:analysis*; D011108:Polymers; D012996:Solutions; D012997:Solvents; D013056:Spectrophotometry, Ultraviolet; D013608:Tablets, Enteric-Coated
chemical_list: D000180:Acrylic Resins; D000897:Anti-Ulcer Agents; D005079:Excipients; D011108:Polymers; D012996:Solutions; D012997:Solvents; D013608:Tablets, Enteric-Coated; C050528:Eudragit RS; D000431:Ethanol; D009853:Omeprazole; D019342:Acetic Acid