Stability of levofloxacin in intravenous solutions in polyvinyl chloride bags

被引:6
作者
Williams, NA
Bornstein, M
Johnson, K
机构
[1] Pharmaceutical Development, R. W. Johnson Pharmaceutical Res. I., Raritan, NJ
[2] Analytical Research and Development, R. W. Johnson Pharmaceutical Res. I., Raritan, NJ
[3] R. W. Johnson Pharmaceutical Res. I., Raritan, NJ 08869
关键词
additives; concentration; containers; diluents; incompatibilities; injections; levofloxacin; mannitol; polyvinyl chloride; precipitation; quinolones; sodium bicarbonate; stability; storage; temperature;
D O I
10.1093/ajhp/53.19.2309
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The stability of levofloxacin in 10 commonly used infusion fluids was studied. Levofloxacin 25-mg/mL injection was diluted to 0.5 and 5 mg/mL in each of the following i.v. infusion fluids: 0.9% sodium chloride injection, 5% dextrose injection, 5% dextrose and 0.9% sodium chloride injection, 5% dextrose and lactated Ringer's injection, 5% sodium bicarbonate injection, Plasma-Lyte 56 and 5% dextrose injection, 5% dextrose and 0.45% sodium chloride and 0.15% potassium chloride injection, 1/6 M sodium lactate injection, sterile water for injection, and 20% mannitol injection. Ten polyvinyl chloride bags were prepared for each solution; two were stored for 3 days at 25 degrees C, two for 7 days at 5 degrees C, two for 14 days at 5 degrees C, two for 13 weeks at -20 degrees C followed by 14 days at 5 degrees C, and two for 26 weeks at -20 degrees C followed by 14 days at 5 degrees C, all in the dark. The solutions were visually examined, tested for turbidity and particulate matter, and subjected to stability indicating high-performance liquid chromatography; solution pH was determined. Levofloxacin was stable in and compatible with all but two of the diluents tested. Precipitation occurred under all conditions in 20% mannitol injection for the 0.5-mg/mt levofloxacin concentration and after storage for 13 weeks at -20 degrees C for the 5-mg/mt concentration. Levofloxacin 0.5 mg/ml in 5% sodium bicarbonate injection formed a precipitate when stored at -20 degrees C for 13 weeks and beyond. Levofloxacin 0.5 and 5 mg/mt was compatible with and stable in 8 of the 10 infusion fluids studied.
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页码:2309 / 2313
页数:5
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