Analytical quality by design-based development of a capillary electrophoresis method for Omeprazole impurity profiling.
J Pharm Biomed Anal
; 248: 116295, 2024 Sep 15.
Article
en En
| MEDLINE
| ID: mdl-38879949
ABSTRACT
Omeprazole (OME) is a proton pump inhibitor used to treat gastroesophageal reflux disease associated conditions. The current study presents an Analytical Quality by Design-based approach for the development of a CE method for OME impurity profiling. The scouting experiments suggested the selection of solvent modified Micellar ElectroKinetic Chromatography operative mode using a pseudostationary phase composed of sodium dodecyl sulfate (SDS) micelles and n-butanol as organic modifier in borate buffer. A symmetric three-level screening matrix 37//16 was used to evaluate the effect of Critical Method Parameters, including Background Electrolyte composition and instrumental settings, on Critical Method Attributes (critical resolution values, OME peak width and analysis time). The analytical procedure was optimized using Response Surface Methodology through a Central Composite Orthogonal Design. Risk of failure maps made it possible to define the Method Operable Design Region, within which the following optimized conditions were selected 72â¯mM borate buffer pH 10.0, 96â¯mM SDS, 1.45â¯%v/v n-butanol, capillary temperature 21 °C, applied voltage 25â¯kV. The method was validated according to ICH guidelines and robustness was evaluated using a Plackett-Burman design. The developed procedure enables the simultaneous determination of OME and seven related impurities, and has been successfully applied to the analysis of pharmaceutical formulations.
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Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Dodecil Sulfato de Sodio
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Omeprazol
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Contaminación de Medicamentos
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Electroforesis Capilar
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Inhibidores de la Bomba de Protones
Idioma:
En
Revista:
J Pharm Biomed Anal
Año:
2024
Tipo del documento:
Article