Development And Validation For The Simultaneous Estimation Of Fluticasone And Vilanterol In Bulk Form And In Its Pharmaceutical Dosage Form By Using RP-HPLC Method

Abstract

A new, simple, rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validation of Fluticasone  and Vilanterol in its pure form as well as in combined marketed formulation. Chromatography was carried out on a Phenomenex Luna C18 (4.6mm×250mm) 5µm particle size column using a mixture of Methanol: Phosphate Buffer (pH-4.2) (37:63% v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 275nm. The retention time of the Fluticasone  and Vilanterol was found to be was 2.133, 3.692 ± 0.02min respectively. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The method produce linear responses in the concentration range of 20-60mg/ml of Fluticasone and 10-30mg/ml of Vilanterol. The inter-day and intra-day precisions were found to be within limits. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations