Naphazoline 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)

DOWNLOAD PDF HERE

1 DEFINITION

Naphazoline Hydrochloride Ophthalmic Solution is a sterile, buffered solution of Naphazoline Hydrochloride in water adjusted to a suitable tonicity. It contains NLT 90.0% and NMT 115.0% of the labeled amount of naphazoline hydrochloride (C₁₄H₁₄N₂ · HCI). 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

Buffer: Dissolve 3 g of monobasic potassium phosphate in 1 L of water, and add 3 mL of triethylamine. Adjust with phosphoric acid to a pH of 3.

Mobile phase: Acetonitrile and Buffer (20:80)

Standard solution: 0.05 mg/mL of USP Naphazoline Hydrochloride RS in Mobile phase

Sample solution: Equivalent to 0.05 mg/mL of naphazoline hydrochloride in Mobile phase from Ophthalmic Solution

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 285 nm or diode array. [NOTE-Use diode array detector to perform Identification test B.]

Column: 4.6-mm x 15-cm; packing L10

Column temperature: 40°

Flow rate: 1.5 mL/min

Injection volume: 10 µL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of naphazoline hydrochloride (C₁₄H₁₄N₂ · HCI) 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 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%-115.0%

4 SPECIFIC TESTS

PH (791): 5.5-7.0

STERILITY TESTS (71): Meets the requirements

5 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in tight containers.

USP REFERENCE STANDARDS (11)

USP Naghazoline Hydrochloride RS