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 sulphate 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 .