A Validated Stability of Omeprazole Sodium Injection in 0.9% Sodium Chloride and 5% Dextrose Solutions by RP-HPLC

Abstract

A specific, accurate, precise and reproducible stability indicating investigation of RP-HPLC method has been developed for omeprazole sodium injection in 0.9% sodium chloride and 5% dextrose solutions. The chromatographic separation was achieved by using the Zorbax Eclipse C8 column (250 mm X 4.6 mm, 5 μm) with a mixture of phosphate buffer (pH 7.2): acetonitrile in the ratio of 75:25 (v/v) as mobile phase at a flow rate of 1.5 ml/min. The UV detection was performed at 280 nm. It was subsequently validated according to ICH and USP guidelines. The described method was linear over the concentration range of 80-240 μg/ml. The specificity of the method shows that the analyte was not interfered by the presence of excipients in both 0.9% sodium chloride and 5% dextrose solutions and the stability of the analyte after reconstitution was found stable for 24 hours in both 0.9% sodium chloride and 5% dextrose solutions. Robustness studies were found satisfactory; hence it proves that the method was robust. The developed method was successfully employed for the determination of omeprazole sodium injection, when it reconstituted with 0.9% sodium chloride and 5% dextrose solutions.