Ofloxacin 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

Ofloxacin Ophthalmic Solution is a sterile aqueous solution of Ofloxacin. It contains NLT 90.0% and NMT 110.0% of the labeled amount of ofloxacin (C₁₈H₂₀FN₃O₄).

2 IDENTIFICATION

A. Thin-Layer Chromatography

Standard stock solution: 3.0 mg/mL of USP Ofloxacin RS in a mixture of chloroform and methanol (1:1)

Standard solution: 0.3 mg/mL of USP Ofloxacin RS from Standard stock solution prepared as follows.

Transfer 5.0 mL of Standard stock solution to a 50-mL volumetric flask, add 5 mL of water, and dilute with a mixture of chloroform and methanol (1:1) to volume.

Sample solution: 0.3 mg/mL of ofloxacin from a portion of Ophthalmic Solution in a mixture of chloroform and methanol (1:1)

Application volume: 2 µL

Developing solvent system: Chloroform, methanol, and a solution (1 in 30) of ammonium hydroxide (150:75:15). Saturate a paper-lined chromatographic chamber with this mixture.

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

3 ASSAY

3.1 Procedure

Mobile phase: Acetonitrile, 0.24% sodium dodecyl sulfate, and glacial acetic acid (400:580:20)

0.05 N hydrochloric acid: Add 4.0 mL of hydrochloric acid to 500 mL of water, dilute with water to 1000 mL, and mix.

System suitability solution: 0.1 mg/mL of USP Ofloxacin RS and 2.4 mg/mL of Propylparaben in acetonitrile

Standard solution: 0.06 mg/mL of USP Ofloxacin RS in 0.05 N hydrochloric acid

Sample solution: 0.06 mg/mL of ofloxacin from Ophthalmic Solution in 0.05 N hydrochloric acid

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 294 nm

Column: 4.6-mm × 25-cm; 5-µm packing L1

Column temperature: 35°

Flow rate: 1.5 mL/min

Injection volume: 20 µL

System suitability

Samples: System suitability solution and Standard solution

Suitability requirements

Resolution: NLT 2 between the propylparaben and ofloxacin peaks, System suitability solution

Tailing factor: NMT 3, Standard solution

Relative standard deviation: NMT 2.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of ofloxacin (C₁₈H₂₀FN₃O₄) in the portion of Ophthalmic Solution taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak area of ofloxacin from the Sample solution

r_S = peak area of ofloxacin from the Standard solution

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

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

Acceptance criteria: 90.0%–110.0%

4 SPECIFIC TESTS

Sterility Tests 〈71〉: It meets the requirements when tested as directed for Membrane Filtration in the test for Sterility of the Product to Be Examined.

pH 〈791〉: 6.0–6.8

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers at controlled room temperature.

USP Reference Standards 〈11〉

USP Ofloxacin RS