METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING METHOD FOR ANALYSIS OF LOSARTAN POTASSIUM IN BULK DRUG AND DOSAGE FORM FORMULATION

摘要

Losartan potassium in tablet dosage form, separation achieved with C 18 column (Kromasil 100-5C18250mm x4.6mm E82860 i.d., 5μm particle), ambient temperature with isocratic mode with mobile phase containing 40:60 Acetonitrile: Buffer consist of 10.5mM of disodium hydrogen phosphate and 10mM potassium dihydrogen phosphate, pH 3.5 adjusted by 10 % Orthophosphoric acid and at flow rate 1.0ml/minute the eluent was monitored at 250nm. The selected chromatographic conditions were found to be effectively separate Losartan potassium 9.98min. The proposed method was found to be linear over the range of 6.4-9.6μg/ml. The drug was subjected to oxidation, acid, alkaline, photolysis and heat stress conditions for degradation. The method was validated for specificity, linearity, accuracy, robustness and solution stability