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

Abstract

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°C over 7 days with protection from light and at 22°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 admixed 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°C without protection from light and for at least 7 days at 4°C with protection from light.