Hydrocortisone Acetate and Neomycin Eye Ointment

Corticosteroid + Aminoglycoside antibacterial.

Hydrocortisone Acetate and Neomycin Eye Ointment is a sterile preparation containing Hydrocortisone Acetate and Neomycin Sulfate in a suitable basis.

The eye ointment complies with the requirements stated under Eye Preparations and with the following requirements.

92.5 to 107.5% of the stated amount.

A. Complies with test A for Identification described under Hydrocortisone and Neomycin Cream using the following solutions. For solution (1) add 10 mL of hexane saturated with acetonitrile to a quantity of the ointment containing 5 mg of Hydrocortisone Acetate and shake for 2 to 3 minutes. Add 10 mL of acetonitrile saturated with hexane, shake for 10 minutes and allow the layers to separate. Centrifuge, filter the acetonitrile layer if necessary, evaporate 5 mL to dryness and dissolve the residue in 5 mL of a mixture of equal volumes of chloroform and ethanol (96%). Solution (2) contains 0.05% w/v of hydrocortisone acetate BPCRS in a mixture of equal volumes of chloroform and ethanol (96%).

B. In the Assay for hydrocortisone acetate the chromatogram obtained with solution (3) shows a peak with the same retention time as the peak due to hydrocortisone acetate in the chromatogram obtained with solution (1).

C. Complies with test C for Identification described under Hydrocortisone and Neomycin Cream. For solution (1) shake a quantity containing 7000 IU of Neomycin Sulfate with 10 mL of chloroform, add 5 mL of water, shake, centrifuge and use the clear, upper layer.

Complies with the test described under Hydrocortisone and Neomycin Cream. For solution (1) disperse a quantity containing 7000 IU of Neomycin Sulfate in 10 mL of chloroform, shake gently with 5 mL of water, centrifuge and use the aqueous layer.

Complies with the test described under Hydrocortisone and Neomycin Cream.

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Solution (1) contains 0.025% w/v of hydrocortisone acetate BPCRS and 0.050% w/v of fluoxymesterone BPCRS (internal standard) in chloroform. For solution (2) shake a quantity of the ointment containing 25 mg of Hydrocortisone Acetate with 20 mL of a 0.25% w/v solution of fluoxymesterone BPCRS in chloroform and several glass beads for 30 minutes. Centrifuge; to 10 mL of the clear, supernatant layer add sufficient chloroform to produce 50 mL.

The chromatographic procedure may be carried out using (a) a stainless steel column (30 cm × 3.9 mm) packed with silica gel for chromatography (10 µm) (µPorasil is suitable), (b) a mixture of 425 volumes of butyl chloride, 425 volumes of butyl chloride saturated with water, 70 volumes of tetrahydrofuran, 35 volumes of methanol and 30 volumes of glacial acetic acid as the mobile phase with a flow rate of 1 mL per minute and (c) a detection wavelength of 254 nm.

Calculate the content of C₂₃H₃₂O₆ in the ointment using the declared content of C₂₃H₃₂O₆ in hydrocortisone acetate BPCRS.

Dissolve a quantity containing 3500 IU in 50 mL of ether, extract the solution with three 30-mL quantities of sterile phosphate buffer pH 8.0 and discard the ether phase. Pass nitrogen through the combined aqueous extracts to remove dissolved ether, dilute to 100 mL with sterile phosphate buffer pH 8.0 and carry out the microbiological assay of antibiotics, Appendix XIV A. The precision of the assay is such that the fiducial limits of error are not less than 95% and not more than 105% of the estimated potency. The upper fiducial limit of error is not less than 90.0% and the lower fiducial limit of error is not more than 115.0% of the stated number of IU per g.

The strength with respect to Neomycin Sulfate is stated as the number of IU (Units) per g.