Ciprofloxacin Ophthalmic Solution
DEFINITION
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).
IDENTIFICATION
• The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• Procedure
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
Chromatographic system
Mode:
LC
Detector:
UV 280 nm
Column:
4.6-mm × 25-cm; packing L1
Flow rate:
1.5 mL/min
Injection size:
20 µL
System suitability
Samples:
Standard solution and System suitability solution
[Note—The relative retention times for the ciprofloxacin ethylenediamine analog and ciprofloxacin are 0.8 and 1.0, respectively. ]
Suitability requirements
Resolution:
NLT 1.5 between the ciprofloxacin ethylenediamine analog and ciprofloxacin, System suitability solution
Capacity factor:
1.5–6 for the ciprofloxacin peak, Standard solution
Column efficiency:
NLT 500 theoretical plates, Standard solution
Tailing factor:
0.9–2.0, Standard solution
Relative standard deviation:
NMT 2%, Standard solution
Analysis
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
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of USP Ciprofloxacin Hydrochloride RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of ciprofloxacin in the Sample solution (mg/mL) |
| Mr1 | = | = molecular weight of ciprofloxacin, 331.34 |
| Mr2 | = | = molecular weight of anhydrous ciprofloxacin hydrochloride, 367.81 |
Acceptance criteria:
90.0%–110.0%
SPECIFIC TESTS
• pH 
791
:
3.5–5.5
791:
3.5–5.5
• Sterility Tests 71:
It meets the requirements when tested as directed under Test for Sterility of the Product to Be Examined, Membrane Filtration.
71:
It meets the requirements when tested as directed under Test for Sterility of the Product to Be Examined, Membrane Filtration.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers, protected from light, at room temperature.
• USP Reference Standards 11
11
USP Ciprofloxacin Ethylenediamine Analog RS 
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)amino]-3-quinolinecarboxylic acid hydrochloride.
C15H16FN3O3·HCl 341.77
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1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)amino]-3-quinolinecarboxylic acid hydrochloride.
C15H16FN3O3·HCl 341.77
USP Ciprofloxacin Hydrochloride RS
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Behnam Davani, Ph.D., M.B.A.
Senior Scientific Liaison 1-301-816-8394 |
(SM12010) Monographs - Small Molecules 1 |
| 71 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2675
Pharmacopeial Forum: Volume No. 35(4) Page 842