Ciprofloxacin Ophthalmic Solution
» Ciprofloxacin Ophthalmic Solution is a sterile, aqueous solution of Ciprofloxacin Hydrochloride. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of ciprofloxacin (C17H18FN3O3).
Packaging and storage— Preserve in tight containers protected from light, at room temperature.
Identification— Dilute a volume of Ophthalmic Solution with water to obtain a test solution containing about 3 mg of ciprofloxacin per mL. Prepare a Standard solution of USP Ciprofloxacin Hydrochloride RS in water containing about 3.5 mg per mL. Proceed as directed in Identification test B under Ciprofloxacin Hydrochloride, beginning with “Separately apply, as 1-cm bands,” except to use 3 µL each of the test solution and the Standard solution instead of 5 µL. The specified result is obtained.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 3.5 and 5.5.
Assay—
Mobile phase— Prepare 0.005 M tetrabutylammonium phosphate, and adjust with phosphoric acid to a pH of 2.0. Prepare a degassed and filtered mixture of this solution and methanol (750:250). Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation— Dissolve an accurately weighed quantity of USP Ciprofloxacin Hydrochloride RS in water to obtain a solution having a known concentration of about 0.14 mg per mL.
Resolution solution— Dissolve a quantity of USP Ciprofloxacin Ethylenediamine Analog RS in a portion of the Standard preparation to obtain a solution containing about 0.01 mg per mL.
Assay preparation— Transfer an accurately measured volume of Ophthalmic Solution, equivalent to about 6 mg of ciprofloxacin, to a 50-mL volumetric flask, dilute with water to volume, and mix.
Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 280-nm detector and a 4.6-mm × 25-cm column containing packing L1. The flow rate is about 1.5 mL per minute. Chromatograph the Resolution solution, and record the responses as directed under Procedure: the relative retention times are about 0.8 for the ciprofloxacin ethylenediamine analog and 1.0 for ciprofloxacin, and the resolution, R, between the ciprofloxacin ethylenediamine analog peak and the ciprofloxacin peak is not less than 1.5. Chromatograph the Standard preparation, and record the responses as directed under Procedure: the capacity factor, k¢, for the ciprofloxacin peak is between 1.5 and 6, the column efficiency is not less than 500 theoretical plates, the tailing factor for the analyte peak is not less than 0.9 and not more than 2.0, and the relative standard deviation for replicate injections is not more than 2%.
Procedure— Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the areas for the ciprofloxacin peaks. Calculate the quantity, in mg, of ciprofloxacin (C17H18FN3O3) in each mL of the Ophthalmic Solution taken by the formula:
(331.34 / 367.81)(50C / V)(rU / rS)
in which 331.34 and 367.81 are the molecular weights of ciprofloxacin and anhydrous ciprofloxacin hydrochloride, respectively; C is the concentration, in mg per mL, of USP Ciprofloxacin Hydrochloride RS in the Standard preparation, calculated on the anhydrous basis; V is the volume, in mL, of Ophthalmic Solution taken; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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Topic/Question Contact Expert Committee
Monograph Behnam Davani, Ph.D., M.B.A.
Senior Scientist
1-301-816-8394
(MDAA05) Monograph Development-Antivirals and Antimicrobials
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 1944
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.