Stability of famotidine in minibags refrigerated and/or frozen

The stability of famotidine 200 micrograms/ml in dextrose 5% injection (D5W) and in NaCl 0.9% (NS) solution in polyvinyl chloride (PVC) minibags was studied when these solutions were stored refrigerated at 4 degrees C for 14 days, or frozen at -20 degrees C for 28 days and then refrigerated for 14 days. Famotidine concentration was determined in the refrigerated samples immediately after compounding (time 0) and also on days 2, 4, 8, and 14 by high-performance liquid chromatography (HPLC). Famotidine concentration was determined by HPLC in frozen samples at time 0 and days 7, 14, 21, 28, 35, and 42. Solutions were also observed for visual changes and pH was tested at these time intervals. Results of the HPLC famotidine analysis demonstrated 94-107 percent recovery of famotidine in D5W and NS at 14 days in refrigerated samples and 98-100 percent recovery of famotidine in minibags frozen for 28 days then refrigerated for 14 days. Analysis of variance showed no time effect on the concentration of famotidine in refrigerated samples (p = 0.741). Linear regression of the frozen minibag data indicated no time effect. Famotidine 200 micrograms/ml is stable in dextrose 5% injection and NaCl 0.9% injection when stored in PVC bags at 4 degrees C for 14 days, or when frozen for 28 days and then subsequently refrigerated for 14 days.