Stability of ranitidine hydrochloride in total nutrient admixtures

Abstract

The stability of ranitidine hydrochloride in total nutrient admixtures (TNAs) containing 5% intravenous fat emulsion was studied. A TNA containing lipids and glucose was prepared aseptically in three ethylene-vinyl acetate bags. Ranitidine hydrochloride 100 mg and 200 mg was added to two of the bags to yield concentrations of 50 micrograms/mL and 100 micrograms/mL, respectively. The third bag served as a control. At 0, 12, 24, 48, and 72 hours, the ranitidine content was measured by high-performance liquid chromatography, the pH of the admixtures was determined, and the bags were visually inspected for signs of color changes, creaming, or precipitates. Particle-size distribution was measured at 72 hours and compared with that in the control bag at time zero. No appreciable changes in pH occurred over 72 hours, and no visual changes were observed. At concentrations of 50 and 100 micrograms/mL of admixture, ranitidine hydrochloride activity declined approximately 80% during the study period. Approximately 10% of the initial concentration was lost in 12 hours. In both cases, there was no variation in particle-size distribution compared with that in the control bag at time zero. Ranitidine hydrochloride appears to be stable for up to 12 hours at room temperature in the admixtures studied, and the lipid emulsion apparently was not altered during this period by ranitidine.