Chemical Stabilities of Cefazolin Sodium and Ranitidine Hydrochloride in 5% Dextrose Injection

Cefazolin Sodium及Ranitidine HCI於5%葡萄糖靜脈注射輸送液中化學安定性之研究

張立乾(Li-Chien Chang) ； 王大鵬(Da-Peng Wang) ； 黃志賢(Chi-Yin Wong)

《Journal of Medical Sciences》 14卷4期 (1994/02) Pp. 255-260

摘要

本以高壓液相層析儀進行探討cefazolin sodium及ranitidine HCl於5%葡萄糖靜脈注射輸送液中化學安定性。以5%葡萄糖靜脈注射輸送液配製含Cefazolin 10.0 mg/ml及Ranitidine 0.5 mg/ml之靜脈注射混合液，分別於4°C及25°C之不同條件下儲存，於2，4，6，17及48小時，分別取樣1 ml，予以測定pH值及外觀之觀察外，同時以發展之安定性指示分析法對Cefazolin及Ranitidine分別予以定量。實驗結果顯示Cefazolin Sodium於4℃及25℃條件下，可儲存2小時，Ranitidine HCl於25℃條件下，可儲存6小時，然於4℃條件下，至少可儲存17小時。

關鍵字

Cefazolin ； Ranitidine ； 葡萄糖靜脈注射輸送液 ； 儲存 ； 高壓液相層析儀 ； 安定性

並列摘要

The chemical stability of cefazolin sodium and ranitidine HCl in 5.0% dextrose injection has been studied using a HPLC method. Cefazolin and ranitidine were diluted with 5.0% dextrose injection to form an admixture with a cefazolin concentration 10.0 mg/ml, and a ranitidine concentration of 0.5 mg/ml. The admixture was stored in 100 ml vented i.v. containers in the dark at 4 and 25 DC, respectively; three containers were stored at each temperature. A 1 ml sample was taken from each container after 2, 4, 6, 17 and 48 hours of storage and visually inspected, tested for pH and assayed by a stability-indicating high-performance liquid chromatographic method. Triplicate studies were done for each storage condition. The solutions of cefazolin sodium were stable for 2 hours (loss in potency of less than 10.0%) at 4°C and 25°C. The ranitidine HCl solutions were stable for only 6 hours at 25°C and for at least 17 hours at 4°C.

並列關鍵字

Cefazolin ； ranitidine ； dextrose ； injection ； storage ； HPLC ； stability