Compatibility and physicochemical stability of ceftriaxone for injection admixed with pantoprazole sodium and ondansetron hydrochloride in different infusion solutions.

Abstract

Objective: The study aimed to analyse the physicochemical stability and compatibility of ceftriaxone sodium (CEF) (2mg/mL) with pantoprazole sodium (PAN) (0.08mg/mL) and ondansetron hydrochloride (OND) (0.008mg/mL) in different infusion solutions, specifically 0.9% sodium chloride injection (NS) and 5% dextrose injection (5D) under varied temperature conditions, including 2°C to 8°C, 25°C, and 37°C at different time intervals.

Method: This study involved determining the content of CEF, PAN and OND in infusion solutions, NS and 5D under varied temperature conditions, including 2°C to 8°C, 25°C, and 37°C at different time intervals using high performance liquid chromatography, visual description of solution mixture, pH measurement, osmolality, particulate matter (both visible and subvisible), as well as assessing the colour and clarity of the solution (measured by absorbance at 420 nm and % transmittance at 650 nm).

Results: No significant changes were observed in pH, osmolality, particulate matter, colour and clarity of admixture in NS up to 48 hours at all conditions. CEF, PAN and OND retained more than 90% of their initial concentration at 2°C to 8°C for 48 hours, 25°C for 8 hours, and 37°C for 8 hours. Also, no significant changes were observed in pH and osmolality of admixture in 5D up to 48 hours at all conditions. CEF, PAN and OND retained more than 90% of their initial concentration at 2°C to 8°C for 4 hours, 25°C for less than 2 hours, and 37°C for less than 2 hours.

Conclusion: This study concludes that the physicochemical stability of a ternary admixture containing CEF, PAN and OND is diluent and temperature dependent. NS ensures acceptable stability, whereas 5D causes rapid degradation. For safety and efficacy, NS is recommended, with refrigerated storage preferred. Based on physicochemical stability data, the use of this parenteral admixture with 5D is not recommended.