Moxifloxacin 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

Moxifloxacin Tablets contain an amount of Moxifloxacin Hydrochloride equivalent to NLT 90.0% and NMT 110.0% of the labeled amount of moxifloxacin (C₂₁H₂₄FN₃O₄)

2 IDENTIFICATION

A. The UV absorption spectrum of the Sample solution exhibits maxima at the same wavelength as that of the Standard solution, as obtained in the Dissolution test.

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

3 ASSAY

PROCEDURE

Buffer: 1.36 g/L of monobasic potassium phosphate in water. Add 2 mL of triethylamine for each liter of the solution and adjust with phosphoric acid to a pH of 1.9.

Solution A: Methanol, n-propyl alcohol, and Buffer (300:34:666)

Mobile phase: Acetonitrile and Solution A (50:1000)

Diluent: Methanol and Buffer (20:80)

Standard solution: 0.09 mg/mL of USP Moxifloxacin Hydrochloride RS in Diluent. Sonicate, if necessary, to dissolve.

Sample stock solution: Nominally 4 mg/mL of moxifloxacin prepared as follows. Transfer NLT 5 Tablets to an appropriate volumetric flask.

Add Diluent to about 40% of the final volume of the flask and sonicate for about 30 min with intermittent shaking. Dilute with Diluent to volume.

Sample solution: 0.08 mg/mL of moxifloxacin prepared as follows. Centrifuge a portion of the Sample stock solution and pipette 5 mL of the supernatant into a 250-mL volumetric flask. Dilute with Diluent to volume. Pass through a suitable filter of 0.45-um pore size.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 293 nm

Column: 4.6-mm x 25-cm; 5-µm packing L11

Column temperature: 45°

Flow rate: 1.5 mL/min

Injection volume: 10 µL

Run time: 10 min

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 moxifloxacin (C₂₁H₂₄FN₃O₄) in the portion of Tablets taken:

                         Result = (r_U/r_S) × (C_S/C_U) × (M_r1/M_r2) × 100

r_U = peak response of moxifloxacin from the Sample solution

r_S = peak response of moxifloxacin from the Standard solution s

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

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

M_r1 = molecular weight of moxifloxacin, 401.43

M_r2 = molecular weight of moxifloxacin hydrochloride, 437.89 

Acceptance criteria: 90.0%-110.0%

4 PERFORMANCE TESTS

4.1 DISSOLUTION (711)

Medium: 0.1 N hydrochloric acid; 900 mL, degassed

Apparatus 2: 50 rpm

Time: 30 min

Standard solution: 9 µg/mL of USP Moxifloxacin Hydrochloride RS in Medium

Sample solution: Pass a portion of the solution through a suitable filter of 0.45-µm pore size. Dilute with Medium to a concentration similar to that of the Standard solution.

Blank: Medium

Instrumental conditions

Mode: UV

Analytical wavelength: 296 nm

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of moxifloxacin (C₂₁H₂₄FN₃O₄) dissolved:

                         Result = (A_U/A_S) × C_S × (M_r1/M_r2)  x V x D x (1/L) x 100

A_U = absorbance of the Sample solution

A_S = absorbance of the Standard solution

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

M_r1 = molecular weight of moxifloxacin, 401.43 

M_r2 = molecular weight of moxifloxacin hydrochloride, 437.89 

V = volume of Medium, 900 mL

D = dilution factor for the Sample solution, if applicable 

L = label claim (mg/Tablet)

Tolerances: NLT 80% (Q) of the labeled amount of moxifloxacin (C₂₁H₂₄FN₃O₄) is dissolved.

4.2 UNIFORMITY OF DOSAGE UNITS (905)

Meet the requirements

5 IMPURITIES

Change to read:

ORGANIC IMPURITIES

Buffer: 1.5 g/L of ^▲tetrabutylammonium _{▲(ERR 1-Oct-2024)} hydrogen sulfate and 1 g/L. of potassium dihydrogen phosphate in water. Add 2 mL of phosphoric acid for each liter of the solution and adjust with triethylamine to a pH of 2.5. Pass through a suitable filter of 0.45-µm pore size.

Solution A: Methanol and Buffer (20:80)

Solution B: Methanol and Buffer (80:20)

Solution C: 0.5 g/L of ^▲tetrabutylammonium _{▲(ERR 1-Oct-2024)} hydrogen sulfate and 1 g/L of monobasic potassium phosphate in water. Add 2 mL of phosphoric acid for each liter of the solution. Pass through a suitable filter of 0.45-µm pore size.

Mobile phase: See Table 1.

Table 1

Diluent: Solution C and 0.1 N sodium hydroxide (1000:10)

Impurity stock solution: 0.02 mg/mL each of USP Moxifloxacin Related Compound F RS and USP Moxifloxacin Related Compound A RS in acetonitrile

System suitability solution: 0.3 mg/mL of USP Moxifloxacin Hydrochloride RS and 0.3 µg/mL each of USP Moxifloxacin Related Compound F RS and USP Moxifloxacin Related Compound A RS in Diluent prepared as follows. Transfer 82 mg of USP Moxifloxacin Hydrochloride RS to a 250-ml volumetric flask and add 4.0 mL of Impurity stock solution. Dilute with Diluent to volume.

Standard solution: 3.3 µg/mL of USP Moxifloxacin Hydrochloride RS in Diluent

Sample solution: Nominally 0.33 mg/mL of moxifloxacin hydrochloride in Diluent prepared as follows. Transfer an amount equivalent to 82 mg of moxifloxacin hydrochloride from finely powdered Tablets (NLT 10) to a 250-mL volumetric flask. Add about 150 mL of Diluent and sonicate for 30 min with intermittent shaking. Dilute with Diluent to volume. Centrifuge a portion of the solution and pass through a suitable filter of 0.45-µm pore size.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 293 and 317 nm

Column: 4 - mm x 25 - 1 cm; 5-µm packing L11

Column temperature: 50°

Flow rate: 1.1 mL/min

Injection volume: 25 µL

System suitability

Samples: System suitability solution and Standard solution

Suitability requirements

Resolution: NLT 2.0 between moxifloxacin related compound F and moxifloxacin, System suitability solution at 293 nm

Peak-to-valley ratio: NLT 1.5 between moxifloxacin and moxifloxacin related compound A, System suitability solution at 293 nm

Tailing factor: NMT 2.0, Standard solution at 293 nm

Relative standard deviation: NMT 10.0%, Standard solution at 293 nm

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of each impurity in the portion of Tablets taken:

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

r_U = peak response of each impurity from the Sample solution

r_S = peak response of moxifloxacin from the Standard solution 

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

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

F = relative response factor for each impurity (see Table 2)

Acceptance criteria: See Table 2. Disregard the peaks eluting before 3 min, after the 8-methoxy quinolonic ethyl ester peak, and any peak less than 0.05%.

Table 2 

^a For identification only. These are process related impurities monitored in the drug substance and not included in the total impurities calculation. 

^b 1-Cyclopropyl-6,8-dimethoxy-1,4-dihydro-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid.

^c 1-Cyclopropyl-8-ethoxy-6-fluoro-1,4-dihydro-7-[(4aS, 7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid.

^d 1-Cyclopropyl-8-fluoro-6-methoxy-1,4-dihydro-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid.

^e 1-Cyclopropyl-6-fluoro-8-hydroxy-1,4-dihydro-7-[(4aS, 7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid.

^f 1-Cyclopropyl-6,7-difluoro-8-hydroxy-4-oxo-3-quinolinecarboxylic acid.

^g 1-Cyclopropyl-6,7-difluoro-8-methoxy-4-oxo-3-quinolinecarboxylic acid.

h Ethyl 1-cyclopropyl-6,7-difluoro-8-methoxy-4-oxo-3-quinolinecarboxylate.

6 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in tight containers and store at controlled room temperature. Avoid high humidity.

USP REFERENCE STANDARDS (11)

USP Moxifloxacin Hydrochloride RS

USP Moxifloxacin Related Compound A. RS

1-Cyclopropyl-6,8-difluoro-1,4-dihydro-7-[(4aS, 7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid.

C₂₀H₂₁F₂N₃O₃       389.40

USP Moxifloxacin Related Compound FRS

1-Cyclopropyl-6-fluoro-8-methoxy-7-[(4aS,7aS)-1-methylhexahydro-1H-pyrrolo[3,4-b]pyridin-6(2H)-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.

C₂₂H₂₆FN₃O₄             415.46