Oxymetazoline 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

Oxymetazoline Hydrochloride Nasal Solution is a solution of Oxymetazoline Hydrochloride in water adjusted to a suitable tonicity. It contains NLT 90.0% and NMT 110.0% of the labeled amount of oxymetazoline hydrochloride (C₁₆H₂₄N₂O · HCl).

2 IDENTIFICATION

A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

Procedure

Mobile phase: Methanol, water, 1 M sodium acetate, and glacial acetic acid (40:46:10:4)

Standard solution: Prepare a solution of USP Oxymetazoline Hydrochloride RS in Mobile phase, having a known concentration approximately equal to the labeled concentration of the Nasal Solution.

Sample solution: Nasal Solution

3.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 280 nm

Column: 4.6-mm × 25-cm; packing L9

Flow rate: 1 mL/min

Injection volume: 20 µL

3.2 System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0% for ve replicate injections

3.3 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of oxymetazoline hydrochloride (C₁₆H₂₄N₂O · 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 the Standard solution (mg/mL)

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

Acceptance criteria: 90.0%–110.0%

4 SPECIFIC TESTS

pH 〈791〉: 4.0–6.5

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

USP Reference Standards 〈11〉

USP Oxymetazoline Hydrochloride RS