Stability of Metoprolol Tartrate in 5% Dextrose Injection or 0.9% Sodium Chloride Injection

Abstract

The stability of metoprolol tartrate 0.40 mg/mL in 5% dextrose injection or 0.9% sodium chloride injection in polyvinyl chloride (PVC) bags stored at 24.0 +/- 2.4 degrees C was studied. Triplicate admixtures of each solution were prepared. A stability-indicating high-performance liquid chromatographic assay was used to determine metoprolol tartrate concentrations. At 0, 6, 12, 24, and 36 hours, samples were visually assessed then assayed in duplicate. Stability was defined as a < 10% decline in metoprolol tartrate concentration from the time 0 determination. No notable color changes or precipitation was observed in any sample. All samples demonstrated a < 7% reduction in metoprolol tartrate concentration over 36 hours. Metoprolol tartrate 0.40 mg/mL admixed in 5% dextrose injection or 0.9% sodium chloride injection in PVC bags and stored at 24.0 +/- 2.4 degrees C was stable for 36 hours.