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/degradants.
- The method was fully validated according to ICH recommendations.