»Xylometazoline Hydrochloride contains not less than 99.0percent and not more than 101.0percent of C16H24N2·HCl,calculated on the dried basis.
Packaging and storage
Preserve in tight,light-resistant containers.
USP Reference standards á11ñ
USP Xylometazoline Hydrochloride RS.
Infrared Absorption á197Mñ
value of the principal spot in the chromatogram of the Identification preparation
corresponds to that of Standard preparation A
as obtained in the test for Chromatographic purity.
between 5.0and 6.6,in a solution (1in 20).
Loss on drying á731ñ
Dry it at 105
for 4hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Dissolve USP Xylometazoline Hydrochloride RS
in methanol,and mix to obtain Standard preparation A
having a known concentration of 100µg per mL.Dilute quantitatively with methanol to obtain Standard solutions
,designated below by letter,having the following compositions:
(µg RSper mL)
with test specimen)
Dissolve an accurately weighed quantity of Xylometazoline Hydrochloride in methanol to obtain a solution containing 20mg per mL.
Dilute a portion of the Test solution
quantitatively with methanol to obtain a solution containing 100µg per mL.
Prepare (1)a solution of 0.5g of potassium iodide in 50mLof water,and (2)a solution of 1.5g of soluble starch in 50mLof boiling water.Just prior to use,mix 10mLof each solution with 3mLof alcohol.
Apply separately 5µLof the Test solution
,5µLof the Identification solution
,and 5µLof each Standard solution
to a suitable thin-layer chromatographic plate (see Chromatography á621ñ
)coated with a 0.25-mm layer of chromatographic silica gel.Position the plate in a chromatographic chamber,and develop the chromatograms in a solvent system consisting of a mixture of methanol and ammonium hydroxide (20:1)until the solvent front has moved about three-fourths of the length of the plate.Remove the plate from the developing chamber,mark the solvent front,and allow the plate to dry under a current of warm air for at least 30minutes.Expose the plate to chlorine gas for not more than 5minutes,and air-dry until the chlorine has dissipated (about 15minutes).Spray the plate with Detection reagent
,and immediately compare the intensities of any secondary spots observed in the chromatogram of the Test solution
with those of the principal spots in the chromatograms of the Standard solutions:
the sum of the intensities of all secondary spots obtained from the Test solution
corresponds to not more than 1.0%.
Dissolve about 500mg of Xylometazoline Hydrochloride,accurately weighed,in 70mLof glacial acetic acid,add 10mLof mercuric acetate TS,and titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically (see Titrimetry á541ñ
),using a calomel-glass electrode system.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 28.08mg of C16
:Kahkashan Zaidi,Ph.D.,Senior Scientific Associate