The present study was undertaken to develop a validated, rapid, simple and economic stability indicating reverse phase HPLC method for estimating Troxipide in bulk and commercial preparation. The Reversed phase chromatographic analysis was performed on a Purospher® STAR RP-18 (250 X 4.6 X 5) with Acetonitrile: 25mM Phosphate buffer, pH 5.0, (30:70) at a flow rate of 1ml/min and detection wavelength of 258 nm. The method was validated for accuracy, precision, reproducibility, specificity, robustness, limit of detection (LOD) and limit of quantification (LOQ), as per International Conference on Harmonization (ICH) Guidelines. Approximately 5- 20% degradation of the drug substance has been considered as reasonable and acceptable for validation of chromatographic assays. Forced degradation studies were performed on a bulk sample of troxipide using 0.1N hydrochloric acid, 0.1N sodium hydroxide, 10 % hydrogen peroxide, heat (100 °C), HPLC grade water and sunlight. The drug was found susceptible to basic, oxidative, hydrolytic degradation and unaffected by acidic, photolytic and thermal degradation. The method was found to be specific for Troxipide in the presence of degradation products with an overall analytical run time of 5 min. A single sharp peak was obtained for Troxipide at Rt of 3.5 ± 0.1 min. The polynomial regression data for the calibration plots exhibited good linear relationship (r = 0.9998) over a concentration range of 100 – 700 μg/ml and the linear regression equation was y=9559x– 668164. Accuracy ranged from 99.98 to 100.81 and the %RSD was found to be less than 2 for both intraday and inter-day precision
