A new RP-HPLC method for the simultaneous estimation of flupentixol and melitracen in its pure and pharmaceutical dosage form as per ICH guidelines

Abstract

A precise, simple, accurate and selective method was developed and validate for simultaneous estimation of Flupentixol and Melitracen in API form and Pharmaceutical Dosage Form. Reversed phase high performance liquid chromatographic (RP-HPLC) method was developed for routine quantification of Flupentixol and Melitracen in the API form as well as in combined pharmaceutical dosage form. Chromatographic separation was achieved on a Phenomenex Gemini C18 (4.6×250mm) 5µm particle size utilizing mobile phase of filtered and degassed mixture of Methanol and Phosphate buffer(pH-3.8) (40:60% v/v) at a flow rate of 1 mL/min with UV detection at 225 nm. The method has been validated for linearity, accuracy and precision. In RP-HPLC method, the calibration graphs were linear in the concentration range of 10-30 μg/ml for Flupentixol and 30-90μg/ml for Melitracen with percentage recoveries are within the limits. The results obtained by RP-HPLC methods are rapid, accurate and precise. Therefore proposed method can be used for routine analysis of Flupentixol and Melitracen in the API form as well as in combined pharmaceutical dosage form.