Abstract
DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF OMEPRAZOLE & ONDANSETRON IN BULK AND ITS PHARMACEUTICAL FORMULATIONS

Dr. Mohammed Shabana Sultana*

ABSTRACT

A new, simple, rapid, selective, precise and accurate isocratic reverse phase high performance liquid Chromatography assay method has been developed for simultaneous estimation of Omeprazole and Ondansetron tablet formulations. The separation was achieved by using column Inertsil ODS-3V (250 x 4.6 mm, 5 μ) in mobile phase consisted of phosphate buffer, methanol and acetonitrile in the ratio of 50:25:25 v/v/v. The flow rate was 1.0 mL/min, column oven temperature 30° C, the injection volume was 10 μL, and detection was performed at 290 nm using a photodiode array detector (PDA), Run time 20 minutes. The retention time of Omeprazole and Ondansetron, was noted to be 8.8 minutes and 11.8 minutes respectively, indicative of rather shorter analysis time. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent.

Keywords: Liquid Chromatography; Omeprazole, Ondansetron, combined dosage forms; Simultaneous estimation, Validation.


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