Ciprofloxacin Ophthalmic Solution
Ciprofloxacin Ophthalmic Solution is a sterile, aqueous solution of Ciprofloxacin Hydrochloride. It contains 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: 0.005 M tetrabutylammonium phosphate solution. Adjust with phosphoric acid to a pH of 2.0.
Mobile phase: Methanol and Solution A (1:3)
Standard solution: 0.14 mg/mL of USP Ciprofloxacin Hydrochloride RS in water
System suitability solution: 0.01 mg/mL of USP Ciprofloxacin Ethylenediamine Analog RS in Standard solution
Sample solution: Equivalent to 0.12 mg/mL of ciprofloxacin from Ophthalmic Solution, in water
Detector: UV 280 nm
Column: 4.6-mm × 25-cm; packing L1
Flow rate: 1.5 mL/min
Injection size: 20 µL
Samples: Standard solution and System suitability solution
[NoteThe relative retention times for the ciprofloxacin ethylenediamine analog and ciprofloxacin are 0.8 and 1.0, respectively. ]
Resolution: NLT 1.5 between the ciprofloxacin ethylenediamine analog and ciprofloxacin, System suitability solution
Capacity factor: 1.56 for the ciprofloxacin peak, Standard solution
Column efficiency: NLT 500 theoretical plates, Standard solution
Tailing factor: 0.92.0, Standard solution
Relative standard deviation: NMT 2%, Standard solution
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of C17H18FN3O3 in the portion of Ophthalmic Solution taken:
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
Acceptance criteria: 90.0%110.0%
• pH 791: 3.55.5
• Sterility Tests 71: It meets the requirements when tested as directed under Test for Sterility of the Product to Be Examined, Membrane Filtration.
• Packaging and Storage: Preserve in tight containers, protected from light, at room temperature.
• 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 2675Pharmacopeial Forum: Volume No. 35(4) Page 842