ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ONDANSETRON BY UHPLC

Abstract

The developed Reverse phase-Ultra High performance liquid chromatographic (RP-UHPLC) method for the analysis of Ondansetron solid dosage form is precise and feasible. The separation was carried out on a Phenomenex C18; 3mm X 50 mm; 2.1microns column, using Mobile phase: Mixture of Buffer: Acetonitrile (500:500) with flow rate at 0.3 mL/min and analysis was performed at wavelength 216 nm. The injection volume was 10 μL. The retention time of the drug was 3.571 min. Robustness conditions like Flow minus (0.2ml/min), Flow plus (0.4ml/min), Wavelength minus and Wavelength plus was maintained. System suitability parameters were not much affected and all the parameters were passed. %RSD was within the limit. The method was validated as per ICH norms. The use of short column made method consumable. The method is also cost effective. The proposed method is useful for rapid analysis of Ondansetron in pharmaceutical dosage forms.