Prednisolone Acetate Ophthalmic Suspension
»Prednisolone Acetate Ophthalmic Suspension is a sterile,aqueous suspension of prednisolone acetate containing a suitable antimicrobial preservative.It may contain suitable buffers,stabilizers,and suspending and viscosity agents.It contains not less than 90.0percent and not more than 115.0percent of the labeled amount of C23H30O6.
Packaging and storage— Preserve in tight containers.
Identification— Transfer a volume of Ophthalmic Suspension,equivalent to about 7.5mg of Prednisolone Acetate,to a test tube,add 5mLof chloroform,and shake.Centrifuge,and apply 20µLof the chloroform layer and 20µLof a Standard solution of USP Prednisolone Acetate RSin chloroform containing 1.5mg per mLon a thin-layer chromatographic plate (see Chromatography á621ñ)coated with a 0.25-mm layer of chromatographic silica gel mixture.Develop the chromatogram in a mixture of chloroform and acetone (4:1)until the solvent front has moved about three-fourths the length of the plate.Mark the solvent front,and locate the spots on the plate by examining under UVlight:the RFvalue of the principal spot obtained from the solution under test corresponds to that obtained from the Standard solution.
Sterility á71ñ: meets the requirements.
pHá791ñ: between 5.0and 6.0.
Assay—
Mobile phase— Prepare a suitably filtered and degassed solution of water and acetonitrile (3:2).Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).
Standard preparation— Dissolve an accurately weighed quantity of USP Prednisolone Acetate RSin a mixture of acetonitrile and water (1:1)to obtain a solution having a known concentration of about 0.1mg per mL.
System suitability preparation— Prepare a solution of prednisolone in a mixture of acetonitrile and methanol (1:1)having a concentration of about 0.1mg per mL.Mix equal volumes of this solution and the Standard preparation.
Assay preparation— Transfer an accurately measured volume of Ophthalmic Suspension,equivalent to about 5mg of prednisolone acetate,to a 50-mLvolumetric flask.Dilute with a mixture of acetonitrile and water (1:1)to volume,and mix.
Chromatographic system (see Chromatography á621ñ)—The liquid chromatograph is equipped with a 254-nm detector and a column that contains packing L1.The flow rate is about 2mLper minute.Chromatograph the Standard preparationand the System suitability preparation,and record the peak responses as directed for Procedure:the relative retention times are 0.5for prednisolone and 1.0for prednisolone acetate,the column efficiency is not less than 7000theoretical plates,the tailing factor is not more than 2.0,and the resolution,R,between prednisolone and prednisolone acetate is not less than 2.0.
Procedure— Separately inject equal volumes (about 10µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of C23H30O6in each mLof the Ophthalmic Suspension taken by the formula:
50(C/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Prednisolone Acetate RSin the Standard preparation,Vis the volume,in mL,of Ophthalmic Suspension taken,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:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1611
Phone Number:1-301-816-8139