Analysis of potential genotoxic impurities in rabeprazole active pharmaceutical ingredient via Liquid Chromatography-tandem Mass Spectrometry, following quality-by-design principles for method development

[Display omitted] •Validation of a novel LC–MS/MS method for quantitation of 2 PGIs in rabeprazole API.•A D-optimal experimental design was employed for method development.•Both numerical and categorical factors were utilized.•Quality-by-Design (QbD) principles were implemented.•Rabeprazole API was...

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Veröffentlicht in:	Journal of pharmaceutical and biomedical analysis 2018-02, Vol.149, p.410-418
Hauptverfasser:	Iliou, Katerina, Malenović, Anđelija, Loukas, Yannis L., Dotsikas, Yannis
Format:	Artikel
Sprache:	eng
Schlagworte:	D-Optimal design LC–MS/MS Potential genotoxic impurities Quality-by-design Rabeprazole
Online-Zugang:	Volltext
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