Compatibility and stability of vancomycin hydrochloride with PVC infusion material in various conditions using stability-indicating high-performance liquid chromatographic assay

被引:19
作者
Khalfi, F
Dine, T
Gressier, B
Luyckx, M
Brunet, C
Ballester, L
Goudaliez, F
Cazin, M
Cazin, JC
机构
[1] UNIV LILLE 2,FAC SCI PHARMACEUT & BIOL,LAB PHARMACOL PHARMACOCINET & PHARM CLIN,F-59006 LILLE,FRANCE
[2] LABS MACOPHARMA,F-59338 TOURCOING,FRANCE
关键词
compatibility; stability; vancomycin; PVC bag; stability-indicating HPLC;
D O I
10.1016/0378-5173(96)04623-6
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The stability and compatibility of vancomycin hydrochloride injection in various diluents with polyvinyl chloride (PVC) containers were studied under different conditions of temperature and light. Drug was diluted to 5 mg/ml and 8 mg/ml in injection solutions for 1 and 24 h-simulated infusions. Vancomycin hydrochloride injection was also prepared to 5 mg/ml in PVC bags and stored at 4 degrees C over 7 days with protection from light and at 22 degrees C over 48 h without protection from light. Physical compatibility with PVC and chemical stability in solution of vancomycin were assessed by visual examination and by measuring the concentration of drug in duplicate with stability-indicating high-performance chromatographic assay. There were no visual change, no color change, no visible precipitation and no loss of the drug. When admired in 0.9% sodium chloride injection or 5% dextrose injection, vancomycin hydrochloride 5 and 8 mg/ml was compatible and stable for 1 and 24 h, respectively, of simulated infusion using PVC bags through PVC administration sets without protection from light. On the other hand, in the same diluents, vancomycin hydrochloride 5 mg/ml was compatible and stable with PVC bags for at least 48 h at 22 degrees C without protection from light and for at least 7 days at 4 degrees C with protection from light.
引用
收藏
页码:243 / 247
页数:5
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