Assay
Mobile phase
Prepare a suitable degassed solution of water, methanol, 1 M sodium acetate, and glacial acetic acid (46:40:10:4).
Assay preparation
Transfer about 25 mg of Oxymetazoline Hydrochloride, accurately weighed, to a 50-mL volumetric flask, dissolve in Mobile phase, dilute with Mobile phase to volume, and mix.
Chromatographic system
(see
Chromatography 621)The liquid chromatograph is equipped with a 280-nm detector and a 4.6-mm × 0.25-m column that contains packing L9. The flow rate is about 1 mL per minute. Chromatograph five replicate injections of the
Standard preparation, and record the peak responses as directed for
Procedure: the tailing factor is not more than 2.0 and the relative standard deviation is not more than 2.0%.
Procedure
Separately inject equal volumes (about 20 µL) of the
Standard preparation and the
Assay preparation into the chromatograph, record the chromatograms, and measure the response for the major peak. Calculate the quantity, in mg, of C
16H
24N
2O·HCl in the portion of Oxymetazoline Hydrochloride taken by the formula:
50C(rU / rS),
in which
C is the concentration, in mg per mL, of USP Oxymetazoline RS in the
Standard preparation, and
rU and
rS are the peak responses obtained from the
Assay preparation and the
Standard preparation, respectively.