Stability of ranitidine in intravenous admixtures stored frozen, refrigerated, and at room temperature.
The stability of ranitidine in concentrations of 0.5, 1.0, and 2.0 mg/mL in admixtures with commonly used i.v. fluids was studied. The admixture vehicles were 0.9% sodium chloride, 5% dextrose, 10% dextrose, 5% dextrose and 0.45% sodium chloride, and 5% dextrose with lactated Ringer's (DLR) injections in polyvinyl chloride bags. Three bags were prepared for each test solution and stored under each of the following conditions: seven days at room temperature (23 +/- 1 degrees C) in normal laboratory lighting, 30 days at 4 degrees C, and 60 days at -20 degrees C followed by either seven days at room temperature (in light) or 14 days at 4 degrees C. Ranitidine content was determined by high-performance liquid chromatography at several intervals. Color, clarity, and pH were also examined. Ranitidine concentrations remained greater than or equal to 90% of initial concentrations under all storage conditions except in the frozen DLR admixtures. Drug loss in the DLR admixtures was greatest at the lower ranitidine concentrations. The only visual changes were yellow color in the thawed DLR admixtures and those containing ranitidine 2.0 mg/mL in 5% dextrose and 0.45% sodium chloride. Slight increases in the pH of some admixtures were noted. Ranitidine is stable for seven days at room temperature and 30 days at 4 degrees C at all concentrations and in all vehicles studied. At the studied concentrations, the drug is stable in admixtures frozen for 60 days and stored for seven days at room temperature or 14 days refrigerated, except in DLR admixtures; these admixtures should not be stored frozen.
Stewart
J T
JT
Department of Medicinal Chemistry, College of Pharmacy, University of Georgia, Athens 30602.
Warren
F W
FW
Johnson
S M
SM
Galante
L J
LJ
D004338:Drug Combinations; D004355:Drug Stability; D004356:Drug Storage; D005615:Freezing; D006863:Hydrogen-Ion Concentration; D007262:Infusions, Intravenous; D011143:Polyvinyl Chloride; D011899:Ranitidine / Q000032:analysis*; D013696:Temperature
D004338:Drug Combinations; D011899:Ranitidine; D011143:Polyvinyl Chloride