Norfloxacin Ophthalmic Solution
» Norfloxacin Ophthalmic Solution is a sterile, aqueous solution of Norfloxacin. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of norfloxacin (C16H18FN3O3).
Packaging and storage Preserve in tight, light-resistant containers, stored at controlled room temperature.
A: Ultraviolet Absorption 197U
Solution: about 0.06 mg of norfloxacin per mL.
Diluent: 0.1 N hydrochloric acid.
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Sterility 71: meets the requirements.
pH 791: between 5.0 and 5.4.
Dilute phosphoric acid solution Prepare a solution of phosphoric acid in water (1 in 1000).
Mobile phase Prepare a filtered and degassed mixture of Dilute phosphoric acid solution and acetonitrile (850:150). Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation Prepare a solution of USP Norfloxacin RS in Dilute phosphoric acid solution having a known concentration of about 0.06 mg per mL.
Resolution solution Prepare a solution of USP Norfloxacin RS and pipemidic acid in Dilute phosphoric acid solution having known concentrations of about 0.06 mg of each per mL.
Assay preparation Dilute an accurately measured volume of Ophthalmic Solution quantitatively and stepwise with Dilute phosphoric acid solution to obtain a solution having a concentration of about 0.06 mg of norfloxacin per mL.
Chromatographic system (see Chromatography 621)The liquid chromatograph is equipped with a 278-nm detector and a 3.9-mm × 30-cm column that contains packing L1. The column temperature is maintained at 50. The flow rate is about 0.5 mL per minute. Precondition the column for about 8 hours with 0.01 M monobasic sodium phosphate buffer adjusted with phosphoric acid to a pH of 4.0. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.8 for pipemidic acid and 1.0 for norfloxacin; and the resolution, R, between the pipemidic acid peak and the norfloxacin peak is not less than 1.2. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the tailing factor for the norfloxacin peak is not more than 2.0; and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure [noteUse peak areas where peak responses are indicated.] Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of norfloxacin (C16H18FN3O3) in each mL of the Ophthalmic Solution taken by the formula:
(L / D)(C)(rU / rS)in which L is the labeled quantity, in mg per mL, of norfloxacin in the Ophthalmic Solution; D is the concentration, in mg per mL, of norfloxacin in the Assay preparation, based on the labeled quantity of norfloxacin in each mL of the Ophthalmic Solution and the extent of dilution; C is the concentration, in mg per mL, of USP Norfloxacin RS in the Standard preparation; and rU and rS are the norfloxacin peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP32NF27 Page 3112