title: Reversed-phase high performance liquid chromatographic method for the determination of lansoprazole, omeprazole and pantoprazole sodium sesquihydrate in presence of their Acid-induced degradation products.
abstract: A simple sensitive, selective and accurate reversed-phase high performance liquid chromatographic method was developed and validated for the quantitative determination of lansoprazole, omeprazole and pantoprazole sodium sesquishydrate in the presence of their acid-induced degradation products. The three compounds were monitored at 280 nm using Nova-Pak C(18) column and a mobile phase consisting of 0.05 M potassium dihydrogen phosphate : methanol : acetonitrile (5 : 3 : 2 v/v/v). Linearity ranges were 2-20 microg ml(-1), 2-36 microg ml(-1) and 0.5-20 microg ml(-1) for lansoprazole, omeprazole and pantoprazole, respectively. The corresponding recoveries were 100.61+/-0.84%, 100.50+/-0.80% and 99.78+/-0.88%. The minimum detection limits were 0.55, 0.54 and 0.03 microg ml(-1) for lansoprazole, omeprazole and pantoprazole, respectively. The method could be successfully applied to the determination of pure, laboratory prepared mixtures and pharmaceutical dosage forms. The results obtained were compared with the reported methods for lansoprazole and pantoprazole or the official U.S.P method for omeprazole.
authors.affiliation: National Organization for Drug Control and Research, Cairo,Egypt. zelsherif@gmail.com
authors.forename: Zeinab Abdelaziz
authors.initials: ZA
authors.lastname: El-Sherif
authors.forename: Afaf Osman
authors.initials: AO
authors.lastname: Mohamed
authors.forename: Mohamed Galal
authors.initials: MG
authors.lastname: El-Bardicy
authors.forename: Mohamed Fayez
authors.initials: MF
authors.lastname: El-Tarras
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000032:analysis*; D000143:Acids / Q000737:chemistry; D000897:Anti-Ulcer Agents / Q000032:analysis; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D064747:Lansoprazole; D009853:Omeprazole / Q000032:analysis*; D000077402:Pantoprazole; D054328:Proton Pump Inhibitors
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000143:Acids; D000897:Anti-Ulcer Agents; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D000077402:Pantoprazole; D009853:Omeprazole