Flurbiprofen Sodium Ophthalmic Solution
»Flurbiprofen Sodium Ophthalmic Solution contains not less than 90.0percent and not more than 110.0percent of the labeled amount of flurbiprofen sodium (C15H12FNaO2·2H2O).
Packaging and storage— Preserve in tight containers.
Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
pHá791ñ: between 6.0and 7.0.
Antimicrobial effectiveness á51ñ: meets the requirements.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Assay—
Diluent,Mobile phase,Standard flurbiprofen related compound Apreparation,Standard preparation,andSystem suitability preparation— Proceed as directed in the Assayunder Flurbiprofen Sodium.
Assay preparation— Use the undiluted Ophthalmic Solution.
Chromatographic system— Proceed as directed in the Assayunder Flurbiprofen Sodium,using a 4.0-mm ×5-cm guard column that contains 5-µm packing L1.
Procedure— Separately inject equal volumes (about 15µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the areas for the major peaks.Calculate the quantity of flurbiprofen sodium (C15H12FNaO2·2H2O)in each mLof the Ophthalmic Solution taken by the formula:
(302.27/244.27)C(rU/rS),
in which 302.27and 244.27are the molecular weights of flurbiprofen sodium dihydrate and anhydrous flurbiprofen,respectively;Cis the concentration,in mg per mL,of USP Flurbiprofen RSin the Standard preparation;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 867
Phone Number:1-301-816-8139