Ciprofloxacin Tablets
DEFINITION
Ciprofloxacin Tablets contain Ciprofloxacin Hydrochloride equivalent to 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:
0.025 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.
Chromatographic system
Mode:
LC
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
System suitability
Samples:
Standard solution and System suitability solution
[Note—The retention time for ciprofloxacin is 6.4–10.8 min. The relative retention times for ciprofloxacin ethylenediamine analog and ciprofloxacin are 0.7 and 1.0, respectively. ]
Suitability requirements
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
Analysis
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
| 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), calculated on the anhydrous basis |
| 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%
PERFORMANCE TESTS
• Dissolution 
711
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
Spectrometric conditions
Mode:
UV
Analytical wavelength:
276 nm
Analysis
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
905:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers.
• 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 |
| 711 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2676
Pharmacopeial Forum: Volume No. 35(4) Page 843