Stability of fluconazole in injectable solutions

Area of Science:

• Pharmaceutical Sciences
• Clinical Pharmacy
• Drug Stability

Background:

• Intravenous fluconazole is widely used for fungal infections.
• Understanding its stability in various intravenous admixtures is crucial for safe administration.
• Limited data exists on fluconazole stability in complex injectable solutions.

Purpose of the Study:

• To evaluate the stability of fluconazole in several common injectable solutions at 25°C for up to 72 hours.
• To determine the compatibility of fluconazole with dextrose, lactated Ringer's, potassium chloride, heparin, theophylline, and morphine sulfate admixtures.

Main Methods:

• Fluconazole (2 mg/mL) was admixed with various injectable solutions in a 1:1 ratio.
• Samples were analyzed for fluconazole concentration using stability-indicating gas chromatography at specified time points (0-72 hours).
• The study focused solely on fluconazole stability, not the stability of other components.

Main Results:

• Fluconazole demonstrated stability for 72 hours in 5% dextrose injection with potassium chloride and with theophylline.
• Fluconazole exhibited stability for 24 hours in 5% dextrose injection, lactated Ringer's injection, and admixtures with heparin or morphine sulfate.
• The stability of other components in the admixtures was not assessed.

Conclusions:

• Fluconazole is stable in specific intravenous admixtures (potassium chloride/dextrose, theophylline/dextrose) for extended periods (72 hours).
• Compatibility is limited to 24 hours in other tested injectable solutions, necessitating careful preparation and administration protocols.
• Further studies are needed to assess the stability of other components in these admixtures.