Stability of levofloxacin in intravenous solutions in polyvinyl chloride bags.
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, 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/mL levofloxacin concentration and after storage for 13 weeks at -20 degrees C for the 5-mg/mL 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/mL was compatible with and stable in 8 of the 10 infusion fluids studied.
R. W. Johnson Pharmaceutical Research Institute, Raritan, NJ 08869, USA. ywilliam@prius.jnj.com
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Williams
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Bornstein
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Johnson
D000890:Anti-Infective Agents / Q000737:chemistry*; D011232:Chemical Precipitation; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004356:Drug Storage; D005947:Glucose / Q000737:chemistry; D006801:Humans; D007262:Infusions, Intravenous; D064704:Levofloxacin; D015242:Ofloxacin / Q000737:chemistry*; D014677:Pharmaceutical Vehicles; D012965:Sodium Chloride / Q000737:chemistry; D012996:Solutions
D000890:Anti-Infective Agents; D014677:Pharmaceutical Vehicles; D012996:Solutions; D012965:Sodium Chloride; D064704:Levofloxacin; D015242:Ofloxacin; D005947:Glucose