Development and Validation of a Stability Indicating RP-HPLC Method for Determination of Ondansetron in Orally Disintegrating Films

A simple, precise, rapid and accurate stability indicating reversed-phase high performance liquidchromatography (RP-HPLC) method is developed for the estimation of ondansetron in orallydisintegrating films. The separation was achieved by using a Waters 2695 HPLC System consistingof analytical column Unisphere-C8 (5μm; 150x4.6mm) and wavelength detector- Waters 2489 UVis used for analysis. The mobile phase consisting of A- phosphate buffer (pH 5.4): acetonitrile in theratio of 72:28 (v/v) is used. The flow rate is 1.0 mlm-1 and the effluents are monitored at 247 nm.The retention time is about 5.0 m. The detector response is linear in the concentration range of 40.0-120.0 μgml-1. The respective linear regression equation being y = 30503 + 65831. The percentageassay of ondansetron is 100.6%. The method is validated as per ICH guideline by determining itsspecificity, accuracy, precision, linearity & range, ruggedness, robustness and system suitability.The results of the study show that the proposed method is simple, rapid, precise and accurate, whichis useful for the routine determination of ondansetron in its orally disintegrating films.