Evaluation of the stability of hydrocortisone sodium succinate in solutions for parenteral use by a validated HPLC-UV method.

Abstract

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 (1and 4 mg/mL), solvent (isotonic saline and glucose), temperature (ambient and 30°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°C) affected HSS stability and significantly reduced the t95% (4.6-6.3h).HSS infusion solutions are physically and chemically stable (˂5% degradation) for at least 6 h if stored below 30°C. The in-use stability may be extended up to 24 h if stored below 24°C.