Simultaneous Quantitative Determination of Formoterol Fumarate and Fluticasone Propionate by Validated Reversed-Phase HPLC Method in Metered dose inhaler

A simple and rapid HPLC method was described for the simultaneous determination of Formoterol fumarate and Fluticasone propionate in Metered Dose Inhaler formulation. The assay involved an isocratic elution of these two component on water spherisorb C8 column (15 cm X 4.6 mm, 5 mm) using a mobile phase composition of Buffer: Acetonitrile: methanol and pH adjusted to 3.0 with dilute orthophosphoric acid. The flow rate was 1.5 mL min-1 and the analytes monitored at 215 nm. Separation was completed within 15 min. Calibration curves were linear with coefficient correlation between 0.99 to 1.0 over a concentration range of 0.41 to 0.85 mg mL-1 for Formoterol fumarate and 6.0 to 37 mg mL-1 for Fluticasone propionate. The limits of detection (LOD) were found to be 0.048 mg mL-1 and 0.05 mg mL-1 for Formoterol fumarate and Fluticasone propionate respectively. All the validation parameters were with in the acceptance range according to ICH norms. Developed method was rapid and convenient, which could be successfully applied for the routine control of both the component.

Author(s): Kusum malik, Davinder kumar, Vivek tomar, Satish. Kaskhedikar, Love soni

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