Oxymetazoline Hydrochloride Ophthalmic 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 Ophthalmic Solution is a sterile, buffered 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). It contains a suitable preservative.

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.

B. The UV spectrum 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, 1 M sodium acetate, glacial acetic acid, and water (40:10:4:46)

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 Ophthalmic Solution.

Sample solution: Use the Ophthalmic Solution.

3.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 280 nm or diode array. [Note—Use diode array detector to perform Identification test B.]

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 Ophthalmic 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 Oxymetazoline Hydrochloride RS in 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〉: 5.8–6.8

Sterility Tests 〈71〉: Meets the requirements

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

USP Reference Standards 〈11〉

USP Oxymetazoline Hydrochloride RS