Phenylephrine Hydrochloride Nasal Jelly

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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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.

1 Packaging and storage

Preserve in tight containers.

USP Reference standards 〈11〉

USP Phenylephrine Hydrochloride RS

2 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.

3 Assay

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(r_U/r_S)

in which C is the concentration, in mg per mL, of USP Phenylephrine Hydrochloride RS in the Standard preparation, and r_U and r_S are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.