High-Performance Liquid Chromatography Assay for Ondansetron in Bulk and Pharmaceutical Formulations

Abstract

Ondansetron (OND), a serotonin type-3 receptor antagonist exhibits antiemetic activity by blocking both centrally as well as peripherally. It is one of the most common empiric options for the treatment of nausea and vomiting of different etiologies such as chemotherapy-induced nausea vomiting (CINV), radiation-induced NV, postoperative NV as well as off-labeled drugs used in pregnancy. For the quantitative determination of ondansetron in bulk and pharmaceutical dosage form, a simple reversed-phase HPLC method was successfully developed and validated. Nucleodur 100 – 10 C18 column (216 mm, 4.6 mm, and 5 μm) was used. The solvent system was methanol: water: acetonitrile (80:15:5, v/v/v), whose pH was adjusted to 2.8 by using a few drops of ortho-phosphoric acid, delivered at a flow rate of 1ml/min. Eluents were detected at a wavelength of 308 nm. The proposed method was found to be specific, sensitive and linear (R² > 0.9999) within a desired range of 0.15 – 5 μg/ml, accurate (99.61 – 100.23%), precise (0.004 – 0.2%), and showed good robustness and ruggedness. The limit of detection and quantification was 0.27 μg/ml and 0.8 μg/ml, respectively. A statistically paired sample t-test for the analysis of precision was employed. The proposed method was applied to different marketed formulations.