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A Stability Indicating HPLC Assay for Prednisolone Sodium Phosphate in Implantable Infusion Pumps
Abstract:Abstract

A stability indicting assay for prednisolone sodium phosphate (PSP) in solutions for implantable infusion pumps was developed. PSP and its major breakdown product, prednisolone, were separated from formulation excipients by reverse phase chromatography on a phenyl-bonded phase column using an acetonitrile-phosphate buffer mobile phase. Detection was by ultraviolet absorbance at 243 mm. Recovery from a synthetic formulation was 101.0 ± 0.4% (n=6). The method was used to monitor the stability of PSP solutions in implantable infusion pumps maintained at 37°C over a 21 day period.
Keywords:Prednisolone Sodium Phosphate  High Performance Liquid Chromatography  Stability-Indicating
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