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3PC-015 Physicochemical stability of cefotaxime in polypropylene syringes at high concentrations for intensive care units

Background Cefotaxime is an antibiotic used to treat severe infections such as in intensive care units (ICUs). The dose of cefotaxime can vary from 3 g to 24 g per day and the literature has demonstrated that continuous administration is the preferred mode of administration. In ICUs, a minimum volume is used for patients requiring fluid restriction, leading to high concentrations of cefotaxime. Purpose The objective was to study the stability of cefotaxime solutions at 83.3 mg/mL and 125 mg/mL, diluted in 0.9% sodium chloride (0.9% NaCl) or 5% glucose (G5%), in polypropylene syringes after preparation and after a 6 hour and 12 hour storage at 20°C–25°C. Material and methods Three syringes for each condition were prepared. At each time of analysis, three samples for each syringe were prepared and analysis by high-performance liquid chromatography (HPLC) coupled to a photodiode array detector. The method was validated according to the International Conference on Harmonisation Q2 (R1). Physical stability was evaluated by visual and subvisual inspection (turbidimetry by UV spectrophotometry at 350, 410 and 550 nm as recommended by the European Consensus Conference). pH and osmolality values were measured. Results For each solvent, cefotaxime solutions at 83.3 mg/mL and 125 mg/mL retained more than 90% of the initial concentration after 12 hours. During the study, pH values decreased slightly, the intensity of the yellow colour increased and absorbance values increased progressively for each wavelength and each condition. An additional peak with a relative retention at 3.01 was also observed after the forced degradation gradually increased up to 4.01% in 0.9% NaCl and 3.17% in G5% of the total surface area of the peaks present on the chromatogram after 12 hours. Conclusion In view of the results and despite the fact that the solutions retained more than 90% of the initial concentration after HPLC analysis, we propose to limit the stability of cefotaxime in 0.9% NaCl and G5% at 83.3 and 125 mg/mL at 6 hours. These stability data of highly concentrated solutions provide additional knowledge to assist ICUs in daily practice. Highly concentrated cefotaxime solutions are unstable after a 6 hour storage and cannot be administered as a daily infusion. References and/or acknowledgements No conflict of interest.