Evaluation of the Stability of Hydrocortisone Sodium Succinate in Solutions for Parenteral Use by a Validated HPLC-UV Method

摘要

This study aimed to determine the in-use stability (t95) of hydrocortisone sodium succinate (HSS) infusion solutions and provide evidence-based guidelines on their usability.HSS infusion solutions were prepared and stored as recommended by the manufacturer and under common conditions in our hospital. The effects of HSS concentration (1 and 4 mg/mL), solvent (isotonic saline and glucose), temperature (ambient and 30 DEG;C), and light on its stability were evaluated using a validated stability-indicating HPLC-UV method. HSS degradation followed first-order kinetics. No significant difference in its stability was observed between the two evaluated concentrations, solvents and light exposure (t95 between 25 and 30 h). Elevated temperature (30 DEG;C) affected HSS stability and significantly reduced the t95 (4.6-6.3 h).HSS infusion solutions are physically and chemically stable (<5 degradation) for at least 6 h if stored below 30 DEG;C. The in-use stability may be extended up to 24 h if stored below 24 DEG;C.