Hydrocortisone Acetate Cream

Corticosteroid.

Hydrocortisone Acetate Cream contains Hydrocortisone Acetate in a suitable basis.

The cream complies with the requirements stated under Topical Semi-solid Preparations and with the following requirements.

90.0 to 110.0% of the stated amount.

A. Carry out the method for thin-layer chromatography, Appendix III A, using silica gel G as the coating substance and a mixture of 77 volumes of dichloromethane, 15 volumes of ether, 8 volumes of methanol and 1.2 volumes of water as the mobile phase. Apply separately to the plate 5 µL of each of the following solutions.

For creams containing more than 0.5% w/w of Hydrocortisone Acetate, prepare two solutions in the following manner. For solution (1) mix a quantity of the cream containing 25 mg of Hydrocortisone Acetate with 10 mL of methanol (90%), add 50 mL of hot hexane and shake. Discard the upper layer, add 5 g of anhydrous sodium sulfate to the lower layer, mix and filter through a glass microfibre filter (Whatman GF/C is suitable). Solution (2) is a mixture of equal volumes of solution (1) and a 0.25% w/v solution of hydrocortisone acetate BPCRS in methanol.

For creams containing 0.5% w/w or less of Hydrocortisone Acetate, prepare solution (1) in the same manner as solution (1) described above but using a quantity of the cream containing 5 mg of Hydrocortisone Acetate. Solution (2) is a mixture of equal volumes of solution (1) and a 0.05% w/v solution of hydrocortisone acetate BPCRS in methanol.

After removal of the plate, allow it to dry in air and spray with alkaline tetrazolium blue solution. The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2), which appears as a single, compact spot.

B. In the Assay, the chromatogram obtained with solution (2) shows a peak with the same retention time as the peak due to hydrocortisone acetate in the chromatogram obtained with solution (1).

Carry out the method for liquid chromatography, Appendix III D, using the following solutions.

For creams containing more than 0.5% w/w of Hydrocortisone Acetate, prepare solutions (1) and (2) in the following manner. For solution (1) dissolve 25 mg of hydrocortisone acetate BPCRS in 45 mL of methanol, add 5 mL of a 0.5% w/v solution of betamethasone (internal standard) in methanol and add sufficient water to produce 100 mL. For solution (2) disperse, by shaking, a quantity containing 25 mg of Hydrocortisone Acetate in 40 mL of a solution prepared by mixing 75 mL of methanol with 25 mL of a 15% w/v solution of sodium chloride. Add 50 mL of hot hexane, shake and separate the lower layer. Repeat the extraction using two 10 mL quantities of the methanolic sodium chloride solution. Add 5 mL of methanol to the combined extracts and sufficient water to produce 100 mL, mix and filter through a glass microfibre filter paper (Whatman GF/C is suitable).

For creams containing 0.5% w/w or less of Hydrocortisone Acetate, prepare solutions (1) and (2) in the following manner. For solution (1) dissolve 5 mg of hydrocortisone acetate BPCRS in 45 mL of methanol and add 5 mL of a 0.110% w/v solution of betamethasone (internal standard) in methanol and sufficient water to produce 100 mL. Prepare solution (2) in the same manner as solution (2) above but use a quantity containing 5 mg of Hydrocortisone Acetate.

For all creams prepare solution (3) in the same manner as solution (2) but adding 5 mL of the appropriate internal standard solution in place of the 5 mL of methanol before diluting to volume.

The chromatographic procedure may be carried out using (a) a stainless steel column (10 cm × 5 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS 1 is suitable), (b) methanol (50%) as the mobile phase with a flow rate of 2 mL per minute and (c) a detection wavelength of 240 nm.

Calculate the content of C₂₃H₃₂O₆ in the preparation being examined using the declared content of C₂₃H₃₂O₆ in hydrocortisone acetate BPCRS.