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Evaluation of Phenylephrine Stability in Polyvinyl Chloride Bags

Purpose Phenylephrine hydrochloride (HCl) is commonly used to maintain adequate blood pressure during shock and shocklike states. Phenylephrine is prepared in concentrated stock vials that require further dilution prior to administration. This study evaluated the physical and chemical stability of phenylephrine in extemporaneously prepared polyvinyl chloride (PVC) bags. Methods Phenylephrine HCl 10 mg/mL solution was diluted with 0.9% sodium chloride for injection to final concentrations of 200 µg/mL and 400 µg/mL and stored at room temperature (23°C-25°C) exposed to fluorescent light. Stability of phenylephrine HCl was evaluated by high-performance liquid chromatography on days 0, 7, 14, 21, 30, 45, and 60. Results Phenylephrine HCl 200 and 400 µg/mL solutions in PVC bags were physically stable during the entire 60-day study period. Phenylephrine HCl retained > 95% of the original concentration. Conclusion Phenylephrine HCl diluted to 200 or 400 µg/mL with 0.9% sodium chloride for injection is both physically and chemically stable for a period of 60 days with ≤5% degradation when stored at room temperature and exposed to fluorescent lighting.