DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF ONDANSETRON HYDROCHLORIDE

The aim of the present study was to develop a validated stability indicating reverse phase high performance liquid chromatography (RP-HPLC) method for estimation of Ondansetron Hydrochloride. An isocratic, RP-HPLC method was developed using HiQ Sil C8 (250 x 4.6 mm, 5 μm) column and 10 mM ammonium acetate buffer (pH 3) and methanol (60:40 v/v) as mobile phase at flow rate of 0.8 ml/min at detection wavelength of 250 nm. The retention time (RT) of drug was 12.280 ± 0.034 min . The method was validated with respect to linearity, precision, accuracy and robustness. The data of linear regression analysis indicated a good linear relationship over the range of 5-30 μg/ml concentrations with a correlation coefficient (R 2 ) of 0.996. Ondansetron hydrochloride was subjected to different stress testing conditions. The developed method was found to be simple, sensitive, selective, accurate, and precise for analysis of Ondansetron hydrochloride and can be adopted for routine analysis of drug in bulk and pharmaceutical dosage form. Keywords: High performance liquid chromatography (HPLC), Ondansetron hydrochloride, Stability indicating, Validation