Maher Moureddine, Jensen Kara J, Lee David, Nix David E
Department of Pharmacy Practice & Science, University of Arizona, Tucson, Arizona.
Int J Pharm Compd. 2016 Jul-Aug;20(4):338-342.
Ampicillin is reported to be stable for only 8 hours in 0.9% sodium chloride with concentrations up to 30 g/L. The purpose of this study was to evaluate if the stability of ampicillin in 0.9% sodium chloride could be extended by adding sodium phosphate for injection using modern highperformance liquid chromatographic methods. Ampicillin was prepared at concentrations of 12 g/L with and without 10 mM sodium phosphate for injection. Stability was assessed under room temperature using a validated, stability- indicating high-performance liquid chromatography assay. The admixtures with added buffer were studied under refrigerated storage as well. Ampicillin 12 g in 1 L normal saline intravenous bags, without buffer addition, was stable for at least 24 hours when stored at room temperature. The time to 90% potency (T90) ranged from 32.0 hours to 41.7 hours. The addition of 10 mM sodium phosphate buffer extended the stability to at least 48 hours with a T90 of 57.6 hours. Ampicillin 12 g/L stored under refrigeration was stable for at least 72 hours. Considering cumulative loss during refrigerated storage and subsequent use at room temperature, the data supports up to 48 hours storage under refrigeration and then up to 24 hours during use at room temperature. Using a stabilityindicating high-performance liquid chromatographic assay, ampicillin 12 g/L in 0.9% sodium chloride is stable for at least 24 hours at room temperature. The addition of 10 mM sodium phosphate for injection extends the stability to at least 48 hours at room temperature.
据报道，氨苄西林在浓度高达30 g/L的0.9%氯化钠溶液中仅能稳定8小时。本研究的目的是使用现代高效液相色谱法评估添加注射用磷酸钠是否可以延长氨苄西林在0.9%氯化钠溶液中的稳定性。制备了浓度为12 g/L的含和不含10 mM注射用磷酸钠的氨苄西林溶液。使用经过验证的、稳定性指示高效液相色谱法在室温下评估稳定性。还研究了添加缓冲剂的混合液在冷藏条件下的情况。1 L生理盐水静脉输液袋中含12 g氨苄西林且未添加缓冲剂时，在室温下储存至少24小时是稳定的。效价降至90%的时间（T90）为32.0小时至41.7小时。添加10 mM磷酸钠缓冲剂可将稳定性延长至至少48小时，T90为57.6小时。12 g/L的氨苄西林在冷藏条件下储存至少72小时是稳定的。考虑到冷藏储存期间以及随后在室温下使用时的累积损失，数据支持在冷藏条件下储存长达48小时，然后在室温下使用长达24小时。使用稳定性指示高效液相色谱法测定，0.9%氯化钠溶液中12 g/L的氨苄西林在室温下至少24小时是稳定的。添加10 mM注射用磷酸钠可将室温下的稳定性延长至至少48小时。
