Development and validation of a new stability indicating reversed phase liquid chromatographic method for the determination of prednisolone acetate and impurities in an ophthalmic suspension

•PAC is the main drug substance in a commercial ophthalmic suspension.•A C18 core–shell column has been used to develop a potency/impurities assay.•This method replaces and outperforms the industry standard USP assay for potency.•The developed method permits quantitation of all known impurities/degr...

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Veröffentlicht in:	Journal of pharmaceutical and biomedical analysis 2015-01, Vol.102, p.261-266
Hauptverfasser:	Marley, Adrian, Stalcup, Apryll M., Connolly, Damian
Format:	Artikel
Sprache:	eng
Schlagworte:	Chromatography, Reverse-Phase - methods Core–shell particles Drug Contamination Drug Stability Impurity analysis Ophthalmic suspension Prednisolone - analogs & derivatives Prednisolone - analysis Prednisolone - chemistry Prednisolone acetate Reversed-phase high performance liquid chromatography Suspensions
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