Phenylephrine Hydrochloride Nasal Solution
»Phenylephrine Hydrochloride Nasal Solution contains not less than 90.0percent and not more than 115.0percent of the labeled amount of C9H13NO2·HCl.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— It responds to the Identificationtest under Phenylephrine Hydrochloride Injection.
Assay—
Mobile phase,Dilution solvent,Standard preparation,Resolution solution,and Chromatographic system— Prepare as directed in the Assayunder Phenylephrine Hydrochloride Nasal Jelly.
Assay preparation— Transfer an accurately measured volume of Nasal Solution,equivalent to about 10mg of phenylephrine hydrochloride,to a 100-mLvolumetric flask.Dilute with Dilution solventto volume,and mix.
Procedure— Separately inject equal volumes (about 20µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of C9H13NO2·HCl in each mLof the Nasal Solution taken by the formula:
100(C/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Phenylephrine Hydrochloride RSin the Standard preparation,Vis the volume,in mL,of Nasal Solution taken,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 1542
Phone Number:1-301-816-8143