QUALITY-BY-DESIGN APPROACH TO SELECTIVE STABILITY INDICATING RP-HPLCMETHOD DEVELOPMENT, OPTIMIZATION AND VALIDATION FOR ESTIMATION OF OSELTAMIVIRBULK DRUG

The present work can show the QBD directed approach for the development, optimization of stability indicating method for Oseltamivir in bulk drug and its degradation products. The chromatographic separation was performed on Hypersil C 18 (250mm×4.6 nm,5µ) with a flow rate of 1 mL/min at 215 nm. The mobile phase employed was Methanol and monohydric buffer (50:50) having pH of 4.2 at 30 °C of column temperature. The degradation studies were carried out for Oseltamivir under the stress condition hydrolysis (acid, base and neutral), oxidation, photolytic and thermal as per ICH guidelines. In alkali degradation chromatogram,morenumber of degradant peaks was appeared along with the risk factor, selectivity of the method.These electivity of the method was established by resolving the resolution of degradant peaks and retention time of drugs by the application of design of experiment.The interaction effect of factors of pH mobile phase,column temperature and %mobile phase were studied through response surface method(RSM) and central composite design(CCD).The optimized selective method was established forthe detection of Oseltamivir along with degradant peaks by optimized conditions has seen there which were proposed by the model for the development. Then the optimized method was validated fortheparameterslikelinearity,accuracy,precisionandrobustnessasperICHguidelines.