Stability indicating analytical method development and validation for the simultaneous estimation of paracetamol and etodolac using Rp-HPLC method in both bulk and pharmaceutical dosage form

A simple and effective RP-HPLC method had been developed for the estimation of Paracetamol and Etodolac in tablet dosage form, using Inertsil ODS C18 (250 x 4.6 mm, 5m.), mobile phase Acetonitrile and water (60:40), detection wavelength at 269 nm, at flow rate of 1ml/min at retention time 3.206 min for paracetamol, 4.825 min for etodolac. Linearity was obtained in the range of 18.46 µg/ml to 55.38 µg/ml for paracetamol and etodolac. The correlation coefficient was found to be 0.999 for the drugs. The Recovery studies were performed for paracetamol and etodolac in the range of 50% - 150 %. The % Assay for paracetamol is 98.85% and etodolac is 99.81 %. Forced Degradation studies were conducted according to the ICH guidelines and the Drug Product was found to be stable in all conditions. Hence, the method could be successfully applied for routine analysis of Paracetamol and Etodolac in combined dosage form.