Hook Roxanne, Neault Ashleigh, Scharrer Devan, Law Shirley, Walker Scott E, Ma Nathan H, Riss Vera
Department of Pharmacy, The Hospital for Sick Children, Toronto, Ontario, Canada.
Department of Pharmacy, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Int J Pharm Compd. 2023 Jul-Aug;27(4):347-351.
Studies have evaluated epinephrine stability in higher concentrations and shorter durations than we require. The objective of this study was to evaluate the chemical stability of epinephrine in syringes at concentrations of 10 mcg/mL in 0.9% sodium chloride at 4°C and 25°C. Solutions of 10 mcg/mL epinephrine in 0.9% sodium chloride were prepared and stored in 10-mL Becton, Dickinson and Company syringes. Three units of each container were stored at 4°C and 25°C. Concentration analysis was completed on study days 0, 2, 7, 14, 21, 28, 42, 56, 72, and 91 using a validated stability-indicating liquid chromatographic method with ultraviolet detection. Chemical stability was based on the intersection of the lower limit of the 95% confidence interval of the observed degradation rate and the time to achieve 90% of the initial concentration (T-90). The analytical method separated degradation products from epinephrine to measure concentration specifically, accurately, and reproducibly. During the study period, all solutions at 4°C retained more than 89.62% of the initial concentration for 91 days. Solutions stored at 25°C retained more than 90% for 21 days. Multiple linear regression revealed significant differences in percent remaining due to study day (P<0.001) and temperature (P=0.002). The calculated T-90, with 95% confidence, was 71.40 days for solutions stored at 4°C but only 12.77 days for solutions stored at 25°C. We conclude that 10 mcg/mL epinephrine solution diluted in 0.9% sodium chloride stored at 4°C is chemically and physically stable for 64 days, with 95% confidence. The syringe may be held at room temperature for up to 24 hours during this period and still retain more than 90% of the initial concentration.
已有研究评估了肾上腺素在比我们要求的更高浓度和更短时间内的稳定性。本研究的目的是评估肾上腺素在4°C和25°C条件下，于0.9%氯化钠溶液中浓度为10 mcg/mL时在注射器中的化学稳定性。制备了10 mcg/mL肾上腺素的0.9%氯化钠溶液，并储存在10 mL的贝克顿·迪金森公司注射器中。每个容器的三个单位分别储存在4°C和25°C。在研究的第0、2、7、14、21、28、42、56、72和91天，使用经过验证的稳定性指示液相色谱法和紫外检测完成浓度分析。化学稳定性基于观察到的降解速率的95%置信区间下限与达到初始浓度90%的时间（T-90）的交点。该分析方法将降解产物与肾上腺素分离，以专门、准确和可重复地测量浓度。在研究期间，4°C下的所有溶液在91天内保持了超过89.62%的初始浓度。25°C下储存的溶液在21天内保持了超过90%。多元线性回归显示，由于研究天数（P<0.001）和温度（P=0.002），剩余百分比存在显著差异。计算得出，4°C下储存的溶液的T-90（95%置信度）为71.40天，而25°C下储存的溶液仅为12.77天。我们得出结论，在4°C储存的0.9%氯化钠中稀释的10 mcg/mL肾上腺素溶液在化学和物理上64天内是稳定的，置信度为95%。在此期间，注射器可在室温下保存长达24小时，仍能保持超过90%的初始浓度。
