Phenylephrine Hydrochloride Nasal Solution

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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1 DEFINITION

Phenylephrine Hydrochloride Nasal Solution contains NLT 90.0% and NMT 115.0% of the labeled amount of phenylephrine hydrochloride (C₉H₁₃NO₂ · HCl).

2 IDENTIFICATION

Change to read:

A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. (USP 1-Aug-2019)

Add the following:

B. The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. (USP 1-Aug-2019)

3 ASSAY

Change to read:

Procedure

Mobile phase: 1.1 g/L of sodium 1-octane sulfonate in a mixture of methanol and water (50:50). Adjust with phosphoric acid to a pH of 3.0.

Diluent: Methanol and water (50:50). Adjust with phosphoric acid to a pH of 3.0.

System suitability solution: 0.1 mg/mL of USP Phenylephrine Hydrochloride RS and 0.1 mg/mL of USP Epinephrine Bitartrate RS in Diluent Standard stock solution: 2 mg/mL of USP Phenylephrine Hydrochloride RS in Diluent

Standard solution: 0.1 mg/mL of USP Phenylephrine Hydrochloride RS in Diluent from the Standard stock solution

Sample solution: Nominally 0.1 mg/mL of phenylephrine hydrochloride in Diluent

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 280 nm. For Identification B, use a diode array detector in the range of 200–400 nm. (USP 1-Aug-2019)

Column: 4.6-mm × 25-cm; packing L1

Flow rate: 1 mL/min

Injection volume: 20 μL

System suitability

Samples: System suitability solution and Standard solution

Suitability requirements

Resolution: NLT 1.5 between phenylephrine and epinephrine, System suitability solution

Tailing factor: NMT 2.0 for the phenylephrine peak, System suitability solution

Relative standard deviation: NMT 2.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of phenylephrine hydrochloride (C₉H₁₃NO₂ · HCl) in the portion of Nasal Solution taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Phenylephrine Hydrochloride RS in the Standard solution (mg/mL)

C_U = nominal concentration of phenylephrine hydrochloride in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–115.0%

4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight, light-resistant containers.

Change to read:

USP Reference Standards 〈11〉

USP Epinephrine Bitartrate RS (USP 1-Aug-2019)

USP Phenylephrine Hydrochloride RS