Phenylephrine Hydrochloride Nasal Jelly
» Phenylephrine Hydrochloride Nasal Jelly contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C9H13NO2·HCl.
Packaging and storage— Preserve in tight containers.
Identification— Dissolve a suitable quantity in water to obtain a solution having a concentration of about 60 µg per mL, and centrifuge, if necessary: the UV absorption spectrum of the solution so obtained exhibits maxima and minima at the same wavelengths as that of a similar solution of USP Phenylephrine Hydrochloride RS, concomitantly measured.
Minimum fill 755: meets the requirements.
Mobile phase— Prepare a mixture of methanol and water (1:1) containing 1.1 g of sodium 1-octanesulfonate per liter, adjust with phosphoric acid to a pH of 3.0, filter, and degas. Make adjustments to the methanol and water ratio, if necessary (see System Suitability under Chromatography 621).
Dilution solvent— Prepare a mixture of methanol and water (1:1), and adjust with phosphoric acid to a pH of 3.0.
Standard preparation— Dissolve an accurately weighed quantity of USP Phenylephrine Hydrochloride RS in Dilution solvent to obtain a Stock standard solution having a known concentration of about 2 mg per mL. Dilute an accurately measured volume of this solution with Dilution solvent to obtain the Standard preparation having a known concentration of about 0.1 mg per mL.
Assay preparation— Transfer an accurately weighed amount of Nasal Jelly, equivalent to about 10 mg of phenylephrine hydrochloride, to a 100-mL volumetric flask. Dilute with Dilution solvent to volume, and mix.
Resolution solution— Transfer 5.0 mL of Stock standard solution to a 100-mL volumetric flask, add 10 mg of USP Epinephrine Bitartrate RS, dilute with Dilution solvent to volume, and mix.
Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 280-nm detector and a 4.6-mm × 25-cm column that contains packing L1. The flow rate is about 1 mL per minute. Chromatograph the Resolution solution: the resolution, R, is not less than 1.5, and the tailing factor for the phenylephrine peak is not more than 2.0. Chromatograph replicate injections of the Standard preparation: 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 responses for the major peaks. Calculate the quantity, in mg, of C9H13NO2·HCl in the portion of Nasal Jelly taken by the formula:
100C(rU / rS)
in which C is the concentration, in mg per mL, of USP Phenylephrine Hydrochloride RS in the Standard preparation, 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.
Topic/Question Contact Expert Committee
Monograph Clydewyn M. Anthony, Ph.D.
(MDCCA05) Monograph Development-Cough Cold and Analgesics
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3285
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.