Ciprofloxacin Tablets contain Ciprofloxacin Hydrochloride equivalent to NLT 90.0% and NMT 110.0% of the labeled amount of ciprofloxacin (C17H18FN3O3).
• The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
Solution A: 0.025 M phosphoric acid. Adjust with triethylamine to a pH of 2.0 ± 0.1.
Solution B: Acetonitrile and Solution A (13:87)
Solution C: 0.025 M phosphoric acid. Adjust with triethylamine to a pH of 3.0 ± 0.1.
Mobile phase: Acetonitrile and Solution C (13:87)
Standard solution: 0.2 mg/mL of USP Ciprofloxacin Hydrochloride RS in Solution B
System suitability solution: 0.05 mg/mL of USP Ciprofloxacin Ethylenediamine Analog RS in the Standard solution
Sample solution: Transfer 5 Tablets to a 500-mL volumetric flask, add 400 mL of Solution B, and sonicate for about 20 min. Dilute with Solution B to volume, mix, and pass through a membrane filter of 0.45-µm pore size. Prepare the equivalent of 0.20 mg/mL of ciprofloxacin from the filtrate with Solution B.
Detector: UV 278 nm
Column: 4.6-mm × 25-cm; packing L1
Column temperature: 30 ± 1
Flow rate: 1.5 mL/min
Injection size: 10 µL
Samples: Standard solution and System suitability solution
[NoteThe retention time for ciprofloxacin is 6.410.8 min. The relative retention times for ciprofloxacin ethylenediamine analog and ciprofloxacin are 0.7 and 1.0, respectively. ]
Resolution: NLT 6 between the ciprofloxacin ethylenediamine analog peak and the ciprofloxacin peak, System suitability requirements
Column efficiency: NLT 2500 theoretical plates from the ciprofloxacin peak, Standard solution
Tailing factor: NMT 2.0 for the ciprofloxacin peak, Standard solution
Relative standard deviation: NMT 1.5%, Standard solution
Samples: Standard solution and Sample solution
Calculate the percentage of C17H18FN3O3 in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
Acceptance criteria: 90.0%110.0%
• Dissolution 711
Medium: 0.01 N hydrochloric acid; 900 mL
Apparatus 2: 50 rpm
Time: 30 min
Sample solution: Pass a portion of the solution under test through a suitable filter. Dilute with Medium, if necessary.
Standard solution: USP Ciprofloxacin Hydrochloride RS in Medium
Analytical wavelength: 276 nm
Samples: Sample solution and Standard solution
Tolerances: An amount of ciprofloxacin hydrochloride (C17H18FN3O3·HCl) equivalent to NLT 80% (Q) of the labeled amount of ciprofloxacin (C17H18FN3O3) is dissolved.
• Uniformity of Dosage Units 905: Meet the requirements
• Packaging and Storage: Preserve in well-closed containers.
• USP Reference Standards 11
USP Ciprofloxacin Ethylenediamine Analog RS
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)amino]-3-quinolinecarboxylic acid hydrochloride.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2676Pharmacopeial Forum: Volume No. 35(4) Page 843