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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 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 in at 25°C.
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