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Analysis of Formoterol Fumarate Dihydrate According to Pharmacopeia Method (ODP-50 4D)

Formoterol fumarate dihydrate is listed in European Pharmacopoeia (EP) and the U.S. Pharmacopoeia (USP). It is necessary for the system suitability for the analysis of impurity I in formoterol fumarate in both pharmacopoeias to satisfy peak-to-valley ratio which is the ratio of the height of impurity I peak to the height of the valley between formoterol fumarate peak and the impurity I peak ≥ 2.5, and the relative retention times for formoterol fumarate and impurity I (about 1.0 and 1.17, respectively). It was confirmed that the all conditions were satisfied when they were analyzed using Asahipak ODP-50 4D (L67 equivalent column).


Sample : 20µL
Formoterol Fumarate Resolution Mixture RS
(Mixture of formoterol and formoterol related compound I) 0.1mg/mL (in H2O)


Column       : Shodex Asahipak ODP-50 4D (4.6mmI.D. x 150mm)
Eluent       : (USP) 4.2g/L tribasic potassium phosphate aq. (pH12.0 adjusted with H3PO4)
               (EP) 5.3g/L tribasic potassium phosphate aq. (pH12.0 adjusted with H3PO4)
Flow rate    : 0.5mL/min
Detector     : UV(225nm)
Column temp. : Room temp. (25°C)

*After analysis, please replace in-column solvent with the shipping solvent and store the column.