Phenylephrine Hydrochloride Nasal Solution
» Phenylephrine Hydrochloride Nasal Solution contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of C9H13NO2·HCl.
Packaging and storage
Preserve in tight, light-resistant containers.
Identification
It responds to the Identification test under Phenylephrine Hydrochloride Injection.
Assay
Mobile phase, Dilution solvent, Standard preparation, Resolution solution, and Chromatographic system
Prepare as directed in the Assay under Phenylephrine Hydrochloride Nasal Jelly.
Assay preparation
Transfer an accurately measured volume of Nasal Solution, equivalent to about 10 mg of phenylephrine hydrochloride, to a 100-mL volumetric flask. Dilute with Dilution solvent to volume, and mix.
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 responses for the major peaks. Calculate the quantity, in mg, of C9H13NO2·HCl in each mL of the Nasal Solution taken by the formula:
100(C / V)(rU / rS)
in which C is the concentration, in mg per mL, of USP Phenylephrine Hydrochloride RS in the Standard preparation, V is the volume, in mL, of Nasal Solution taken, and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4301
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