NEWER RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF FORMOTEROL FUMARATE AND BUDESONIDE IN DOSAGE FORM

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validation of Formoterol Fumarate and Budesonide, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Phenomenex Gemini C18 (4.6×250mm) 5µ column using a mixture of Methanol: TEA Buffer (65:35 v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 230nm. The retention time of the Formoterol Fumarate and Budesonide was 2.121, 3.643 ±0.02min respectively. The method produce linear responses in the concentration range of 10-50mg/ml of Formoterol Fumarate and 20-100mg/ml of Budesonide.  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.

Keywords: Formoterol Fumarate, Budesonide, RP-HPLC, validation.