A validated stability-indicating HPLC assay method to investigate stability of Pantoprazole injection with injectable solutions (5 % Dextrose injection and 0.9% Sodium Chloride injection)

Abstract

Intravenous Pantoprazole is an alternative short-term treatment for patients with gastro esophageal reflux disease (GERD) who cannot take pantoprazole tablets. The stability of reconstituted solutions of Pantoprazole Injection in 5% Dextrose and 0.9% Sodium Chloride is critical before intravenous infusion, Physical stability (by pH measurement) and chemical stability (by measuring the concentration) in solution of Pantoprazole was assessed. A stability-indicating reversed phase High-Performance liquid chromatographic (HPLC) assay method was developed and validated. The reconstituted solutions were kept under storage at room temperature (25°C ±2°C) and tested as per method at 0,4,8,12,18 & 24 hours. The validation study concluded that assay method is suitable to investigate the stability of Pantoprazole injection in injectable solutions (5% Dextrose injection and 0.9% Sodium Chloride injection) and solutions are stable for up to 24 hours at 25°C.