DEVELOPMENT AND VALIDATION OF A RP-HPLC-PDA METHOD FOR SIMULTANEOUS DETERMINATION OF FLUTICASONE AND SALMETEROL IN BULK AND PHARMACEUTICAL DOSAGE FORM
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Abstract
A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validation of Fluticasone and Salmeterol, in its pure form as well as in tablet dosage form. Chromatography was carried out on a X-Terra C18 (4.6×250mm) 5µ column using a mixture of Methanol: Acetonitrile: Water (50:35:15%v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 280nm. The retention time of the Fluticasone and Salmeterol was 1.6, 3.2 ±0.02min respectively. The method produce linear responses in the concentration range of 40-200µg/ml of Fluticasone and 5-25µg/ml of Salmeterol. 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.
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