title: Ultra-fast gradient LC method for omeprazole analysis using a monolithic column: assay development, validation, and application to the quality control of omeprazole enteric-coated pellets.
abstract: A method was optimized for the analysis of omeprazole (OMZ) by ultra-high speed LC with diode array detection using a monolithic Chromolith Fast Gradient RP 18 endcapped column (50 x 2.0 mm id). The analyses were performed at 30 degrees C using a mobile phase consisting of 0.15% (v/v) trifluoroacetic acid (TFA) in water (solvent A) and 0.15% (v/v) TFA in acetonitrile (solvent B) under a linear gradient of 5 to 90% B in 1 min at a flow rate of 1.0 mL/min and detection at 220 nm. Under these conditions, OMZ retention time was approximately 0.74 min. Validation parameters, such as selectivity, linearity, precision, accuracy, and robustness, showed results within the acceptable criteria. The method developed was successfully applied to OMZ enteric-coated pellets, showing that this assay can be used in the pharmaceutical industry for routine QC analysis. Moreover, the analytical conditions established allow for the simultaneous analysis of OMZ metabolites, 5-hydroxyomeprazole and omeprazole sulfone, in the same run, showing that this method can be extended to other matrixes with adequate procedures for sample preparation.
authors.affiliation: Universidade de São Paulo, Departamento de Física e Química, Faculdade de Ciências Farmacêuticas de Ribeirão Preto, Ribeirão Preto, Brazil.
authors.forename: Keyller Bastos
authors.initials: KB
authors.lastname: Borges
authors.forename: Antonio José Macías
authors.initials: AJ
authors.lastname: Sánchez
authors.forename: Mônica Tallarico
authors.initials: MT
authors.lastname: Pupo
authors.forename: Pierina Sueli
authors.initials: PS
authors.lastname: Bonato
authors.forename: Isidro González
authors.initials: IG
authors.lastname: Collado
mesh_terms: D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D007202:Indicators and Reagents; D009853:Omeprazole / Q000032:analysis*; D054328:Proton Pump Inhibitors / Q000032:analysis*; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D012996:Solutions; D013608:Tablets, Enteric-Coated
chemical_list: D007202:Indicators and Reagents; D054328:Proton Pump Inhibitors; D012996:Solutions; D013608:Tablets, Enteric-Coated; D009853:Omeprazole