Surgical Intensive Care Unit, Denver Health Medical Center, Denver, CO, USA.
Am J Health Syst Pharm. 2013 Aug 1;70(15):1336-41. doi: 10.2146/ajhp120390.
The stability of dexmedetomidine in polyvinyl chloride (PVC) bags containing 0.9% sodium chloride injection was studied.
Dexmedetomidine solutions (4, 8, 12, and 20 μg/mL; n = 6 for each) were prepared by removing 2, 4, 6, and 10 mL of 0.9% sodium chloride injection, respectively, from 50-mL PVC bags and injecting 2, 4, 6, and 10 mL of dexmedetomidine 100 μg/mL, respectively. To ensure a homogeneous mixture, the contents of each bag was manually mixed initially and before each sample was removed. All compounding was conducted by a single pharmacist using aseptic technique in a horizontal-laminar-airflow hood at 25 °C. Forced-degradation studies were conducted at 70 ± 1 °C. Stability samples were analyzed using high-performance liquid chromatography electrospray ionization-tandem mass spectrometry (LC/MS-MS) and high-performance liquid chromatography-ultraviolet-light (HPLC/UV) absorbance. Forced-degradation samples were monitored using LC/MS-MS, HPLC/UV, and gas chromatography-MS.
Dexmedetomidine solutions were very stable at 23 ± 2 °C at all four concentrations over the 48-hour testing period. As determined via LC/MS-MS and HPLC/UV methods, over 97% of the initial concentration of dexmedetomidine remained after 48 hours. Extensive HPLC/UV active degradation products could be observed in basic conditions; only minor UV active degradation products were observed in acidic, oxidative, and photochemical conditions.
Dexmedetomidine hydrochloride 4, 8, 12, and 20 μg/mL stored in PVC bags at 23 ± 2 °C was stable for 48 hours, despite a slight decrease in solution pH seen with increasing dexmedetomidine concentrations.
研究含 0.9%氯化钠注射液的聚氯乙烯（PVC）袋中盐酸右美托咪定的稳定性。
通过从 50-mL PVC 袋中分别取出 2、4、6 和 10 mL 0.9%氯化钠注射液，并分别注入 2、4、6 和 10 mL 100 μg/mL 的盐酸右美托咪定，制备 4、8、12 和 20 μg/mL 的盐酸右美托咪定溶液（n = 6 每个）。为确保均匀混合，最初和每次取样前手动混合每个袋子的内容物。所有混合均由一名药剂师在 25°C 的水平层流空气罩中使用无菌技术进行。强制降解研究在 70±1°C 下进行。使用高效液相色谱电喷雾串联质谱（LC/MS-MS）和高效液相色谱-紫外光（HPLC/UV）吸收度分析稳定性样品。使用 LC/MS-MS、HPLC/UV 和气相色谱-MS 监测强制降解样品。
在 48 小时测试期间，所有四个浓度的盐酸右美托咪定溶液在 23±2°C 下均非常稳定。通过 LC/MS-MS 和 HPLC/UV 方法确定，在 48 小时后，盐酸右美托咪定的初始浓度仍保持在 97%以上。在碱性条件下可以观察到广泛的 HPLC/UV 活性降解产物；在酸性、氧化和光化学条件下仅观察到少量的 UV 活性降解产物。
在 23±2°C 下储存在 PVC 袋中的盐酸右美托咪定 4、8、12 和 20 μg/mL 在 48 小时内稳定，尽管随着盐酸右美托咪定浓度的增加，溶液 pH 值略有下降。
