Naphazoline 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)

DOWNLOAD PDF HERE

1 DEFINITION

Naphazoline Hydrochloride Nasal Solution is a solution of Naphazoline Hydrochloride in water adjusted to a suitable pH and tonicity. It contains NLT 90.0% and NMT 110.0% of the labeled amount of naphazoline hydrochloride (C₁₄H₁₄N₂ · HCI).

2 IDENTIFICATION

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

3 ASSAY

PROCEDURE

Mobile phase: Dissolve 1.1 g of sodium 1-heptanesulfonate in 400 mL of water. Add 250 mL of acetonitrile and 10 mL of glacial acetic acid, and dilute with water to 1000 mL. Sonicate for 10 min to obtain a solution having a pH of about 3.5.

Standard solution: 0.25 mg/mL of USP Naphazoline Hydrochloride RS in water

Sample solution: Equivalent to 0.25 mg/mL of naphazoline hydrochloride in water from Nasal Solution

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 280 nm

Column: 4-mm x 30-cm; packing L11

Flow rate: 2 mL/min

Injection volume: 15 μl

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 1.5%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of naphazoline hydrochloride (C₁₄H₁₄N₂ · HCI) 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 Naphazoline Hydrochloride RS in the Standard solution (mg/mL)

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

Acceptance criteria: 90.0%-110.0%

4 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in tight, light-resistant containers.

USP REFERENCE STANDARDS (11)

USP Naphazoline Hydrochloride RS