Stability of commonly used antibiotics solutions in the accufuser® elastometric infusion device under recommended storage and used conditions

Abstract

Objectives: The stability of two kinds of solution of penicillin G potassium [PEN-K, 10K U/mL in 5% dextrose water, D5W and 50K U/mL in 0.9% sodium chloride in water, NS) into the intravenous infusion device, Accufuser®, storage were evaluated at controlled temperature (CT, 4±2°C and RT, 25±2°C) during 6 weeks. Methods: Studies were performed using both NS (PEN-K 50K U/mL) and D5W (PEN-K 10K U/mL) injectable solutions. The resulting solutions were transferred to Accufuser® infusion device for storage at CT or RT. Effects of period of storage (from 0 to 6 weeks) and temperature (CT and RT) on the physical appearance and concentrations of PEN-K were determined by visual clarity, pH and antibiotic concentrations by measurement with stability-indicating high-performance liquid chromatography (HPLC) method. Results: In NS (50 K U/mL) and D5W (10K U/mL) solutions, concentrations of PEN-K were slightly change and remained 94.18 and 83.42% at CT after 1 week, respectively. Otherwise, these were rapidly decreased with time and reached to 74.65 and 75.59% in NS (50K U/mL) and D5W (10K U/mL) solutions at RT after 48 h, respectively. Moderate decrement of pH was observed in cold storage and it was shown no significant changes at 6 weeks in the RT conditions. In CT, no significant changes in physical appearance or color of the solutions were observed during the study. Conclusion: Two kinds of PEN-K D5W(10K U/mL) and NS(50K U/mL) solution were shown different chemical stability with time in Accufuser® infusion device without any significant physical change and retained about 70% of initial concentration after 48 h in RT and 80 % after 2 weeks in CT, respectively. We suggested that PEN-K solutions of 50K U/mL NS and 10K U/mL D5W in an Accufuser® infusion device should be preferentially applicable only in CT for 48 h in clinical situations.