QbD APPROACH FOR STABILITY INDICATING HPLC METHOD FOR DETERMINATION OF ARTEMETHER AND LUMEFANTRINE IN COMBINED DOSAGE FORM

Abstract

The present paper reports a highly selective, sensitive and robust stability indicating RP-HPLC method using QbDapproach, developed and validated for determination of Artemether and Lumefantrine in combined dosage form. Theexperimental design describes the scouting of the key HPLC method components including mobile phase and pH.Their interrelationships are studied and optimized conditions are obtained for each combination of mobile phase andpH with the help of design expert 10.0 version. Optimal chromatographic conditions were obtained usingPhenomenex, Gemini 5u C-18 column combined with a mixture of Acetonitrile: Buffer (35:65 v/v) mobile phase, pHadjusted to 2.5 with buffer H3PO4. The flow rate was 1.5ml/min. The injection volume was 10μl. Retention time forArtemether and Lumefantrine were found 4.44 and 7.84 min respectively. The method was linear with 2-6μg/ml and12-36μg/ml for Artemether and Lumefantrine respectively. The LOD and LOQ were 0.000278 μg/ml and 0.000841μg/ml respectively. This method found to have a good percentage recovery in forced degradation study using acid,base, oxidation, photolytic, thermal and neutral conditions indicates well separation of both the drugs with otherdegradation products. All validation parameters were within the acceptance limits.