Ofloxacin Tablets

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 Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of ofloxacin (C₁₈H₂₀FN₃O₄).

2 IDENTIFICATION

Change to read:

A. (USP 1-Dec-2024) The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

Add the following:

B. The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. (USP 1-Dec-2024)

3 ASSAY

Change to read:

3.1 Procedure

Buffer: (USP 1-Dec-2024) Dissolve 2.72 g/L (USP 1-Dec-2024) of monobasic potassium phosphate in water.

Adjust with diluted phosphoric acid to a pH of 3.3. (USP 1-Dec-2024)

Mobile phase: Acetonitrile and Buffer (12:88) (USP 1-Dec-2024)

Diluent 1: Methanol and glacial acetic acid (75:25) (USP 1-Dec-2024)

Diluent 2: Acetonitrile and water (10:90) (USP 1-Dec-2024)

Standard stock solution: 1 mg/mL of USP Ofloxacin RS in Diluent 1

Standard solution: 0.02 mg/mL (USP 1-Dec-2024) of USP Ofloxacin RS from the Standard stock solution in Diluent 2

Sample stock solution: Nominally 1 mg/mL of ofloxacin from Tablets prepared as follows. Transfer a suitable portion of ofloxacin from powdered Tablets to a suitable volumetric flask. Add 70% of the flask volume of Diluent 1, sonicate for 20 min, and dilute with Diluent 1 to volume. Pass the solution through a suitable filter of 0.45-µm pore size, and collect the filtrate. (USP 1-Dec-2024)

Sample solution: Nominally 0.02 mg/mL of ofloxacin from the Sample stock solution in Diluent 2. (USP 1-Dec-2024)

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 294 nm.

For Identification B, use a diode array detector in the range of 200–400 nm. (USP 1-Dec-2024)

Column: 4.6-mm × 10-cm; 3.5-μm (USP 1-Dec-2024) packing L1

Flow rate: 1 mL/min

Injection volume: 20 µL

Run time: NLT 1.5 times the retention time of the ofloxacin peak (USP 1-Dec-2024)

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 1.0% (USP 1-Dec-2024)

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of (USP 1-Dec-2024) ofloxacin (C₁₈H₂₀FN₃O₄) in the portion of Tablets taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of ofloxacin (USP 1-Dec-2024) from the Sample solution

r_S = peak response of ofloxacin (USP 1-Dec-2024) from the Standard solution

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

C_U = nominal concentration of ofloxacin in (USP 1-Dec-2024) the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Change to read:

4.1 Dissolution 〈711〉

Medium: 0.1 N hydrochloric acid; 900 mL

Apparatus 1: 100 rpm

Time: 30 min

Standard stock solution: 0.44 mg/mL of USP Ofloxacin RS in methanol

Standard solution: 0.0088 mg/mL (USP 1-Dec-2024) of USP Ofloxacin RS from the Standard stock solution in (USP 1-Dec-2024) Medium

Sample solution: Pass a portion of the solution under test through a suitable filter of (USP 1-Dec-2024) 0.45-µm pore size. (USP 1-Dec-2024)

Dilute a portion of the filtrate with Medium to obtain a final theoretical concentration of 0.0088 mg/mL, (USP 1-Dec-2024) assuming complete dissolution of the label claim.

Spectrometric conditions

(See Ultraviolet-Visible Spectroscopy 〈857〉.)

Mode: UV-Vis

Analytical wavelength: 294 nm

Path length: (USP 1-Dec-2024) 1 cm

Blank: Medium

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of (USP 1-Dec-2024) ofloxacin (C₁₈H₂₀FN₃O₄) dissolved:

Result = (A_U/A_S) × C_S × V × D × (1/L) × 100

A_U = absorbance from the Sample solution

A_S = absorbance from the Standard solution

C_S = concentration of ofloxacin in the Standard solution (mg/mL)

V = volume of Medium, 900 mL

D = dilution factor for the Sample solution

L = label claim (mg/Tablet)

Tolerances: NLT 80% (Q) of the labeled amount of ofloxacin (C₁₈H₂₀FN₃O₄) is dissolved.

4.2 Uniformity of Dosage Units 〈905〉: Meet the requirements

5 IMPURITIES

Change to read:

5.1 Organic Impurities

Buffer: (USP 1-Dec-2024) 2.72 g/L (USP 1-Dec-2024) of monobasic potassium phosphate in water. Adjust with diluted phosphoric acid to a pH of 3.3. (USP 1-Dec-2024)

Solution A: Acetonitrile and Buffer (12:88) (USP 1-Dec-2024)

Solution B: Acetonitrile and Buffer (60:40) (USP 1-Dec-2024)

Mobile phase: See Table 1.

Table 1 (USP 1-Dec-2024)

Sensitivity solution: 1 µg/mL of USP Ofloxacin RS in methanol (USP 1-Dec-2024)

Standard solution: 0.002 mg/mL (USP 1-Dec-2024) of USP Ofloxacin RS in methanol

Sample solution: Nominally 1 mg/mL of ofloxacin from Tablets prepared as follows. Transfer a suitable portion of ofloxacin from powdered Tablets to a suitable volumetric flask. Add 70% of the flask volume (USP 1-Dec-2024) of methanol and sonicate for 20 min. Dilute with methanol to volume. Pass a portion of this solution through a filter having a 0.45-µm pore size, (USP 1-Dec-2024) discarding the first 5 mL.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 294 nm

Column: 4.6-mm × 10-cm; 3-µm (USP 1-Dec-2024) packing L1

Flow rate: 1 mL/min

Injection volume: 10 µL

System suitability

Samples: Sensitivity solution and (USP 1-Dec-2024) Standard solution

[Note—The relative retention times in Table 2 are provided as information that could aid in peak assignment.]

Table 2 (USP 1-Dec-2024)

^a (USP 1-Dec-2024) 2,3-Dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid▲

^b (USP 1-Dec-2024) 9,10-Difluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid▲

Suitability requirements

Tailing factor: NMT 2.0, Standard solution

Relative standard deviation: NMT 5.0%, Standard solution

Signal-to-noise ratio: NLT 10, Sensitivity solution (USP 1-Dec-2024)

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of any (USP 1-Dec-2024) impurity in the portion of Tablets taken:

Result = (r_U/r_S) × (C_S/C_U) × (1/F) × 100

r_U = peak response of each (USP 1-Dec-2024) impurity from the Sample solution

r_S = peak response 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)

F = relative response factor (USP 1-Dec-2024) (see Table 3)

Acceptance criteria: See Table 3. The reporting threshold is 0.1%.

Table 3 (USP 1-Dec-2024)

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers. Store at controlled room temperature.

USP Reference Standards 〈11〉

USP Ofloxacin RS