Identification
A:
Infrared Absorption á197Mñ.
Solution
:100µg per mL.
Medium:
water.
Absorptivities at 279nm,calculated on the dried basis,do not differ by more than 3.0%.
C:
To a solution of about 50mg in 3mLof water add 1mLof 6Nammonium hydroxide,filter,and acidify the filtrate with nitric acid:the filtrate responds to the tests for Chloride á191ñ.
Assay
Mobile phase
Prepare a suitable degassed solution of water,methanol,1Msodium acetate,and glacial acetic acid (46:40:10:4).
Assay preparation
Transfer about 25mg of Oxymetazoline Hydrochloride,accurately weighed,to a 50-mLvolumetric flask,dissolve in Mobile phase,dilute with Mobile phaseto volume,and mix.
Chromatographic system
(see
Chromatography á621ñ)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 1mLper 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 2.0and the relative standard deviation is not more than 2.0%.
Procedure
Separately inject equal volumes (about 20µL)of the
Standard preparationand the
Assay preparationinto 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
Cis the concentration,in mg per mL,of USP Oxymetazoline RSin the
Standard preparation,and
rUand
rSare the peak responses obtained from the
Assay preparationand the
Standard preparation,respectively.