Stability and compatibility of doxofylline with phentolamine mesilate in 0.9% sodium chloride or 5% dextrose injection for intravenous infusion.

WHAT IS KNOWN AND OBJECTIVE

The use of extemporaneously prepared admixtures of drugs must be supported by documentation of their chemical stability. The objective was to assess the physical compatibility and the chemical stability of doxofylline with phentolamine mesilate in 0.9% sodium chloride or 5% dextrose injection for intravenous infusion.

METHODS

Total volumes of 20 and 1 mL of doxofylline solution and phentolamine mesilate solution, respectively, were added to 250 mL polyolefin bags containing 5% dextrose injection or 0.9% sodium chloride injection. Bags were stored for 24 h at 20-25 °C. Chemical compatibility was measures with high-performance liquid chromatography, and physical compatibility was determined visually.

RESULTS

The samples were clear and colourless when viewed in normal fluorescent room light. The pH value and particulate content of the admixtures exhibited little change. The retentions of the initial concentration of doxofylline and phentolamine mesilate in the admixtures were within 97-105%. Doxofylline and phentolamine mesilate were stable in 5% dextrose injection or in 0.9% sodium chloride for up to 24 h at 20-25 °C.

WHAT IS NEW AND CONCLUSION

Doxofylline and phentolamine mesilate mixed in both 5% dextrose injection and 0.9% sodium chloride injection in 250 mL multilayer polyolefin bags at concentrations of 0.74 mg/mL and 36.9 μg/mL, respectively, were stable for up to 24 h at 20-25 °C.