Edition: BP 2025 (Ph. Eur. 11.6 update)
Action and use
Corticosteroid.
DEFINITION
Hydrocortisone Ointment contains Hydrocortisone in a suitable basis.
The ointment complies with the requirements stated under Topical Semi-solid Preparations and with the following requirements.
Content of hydrocortisone, C21H30O5
90.0 to 110.0% of the stated amount.
IDENTIFICATION
A. Complies with test A for Identification described under Hydrocortisone Cream but preparing solution (1) in the following manner. For ointments containing more than 0.5% w/w of Hydrocortisone, disperse a quantity containing 25 mg of Hydrocortisone in 5 mL of hot hexane, cool, extract with 10 mL of methanol (90%) and filter. For ointments containing 0.5% w/w or less of Hydrocortisone, disperse a quantity containing 5 mg of Hydrocortisone in 50 mL of hot hexane, cool, extract with 10 mL of methanol (90%) and filter.
B. In the Assay, the chromatogram obtained with solution (2) shows a peak with the same retention time as the peak due to hydrocortisone in the chromatogram obtained with solution (1).
ASSAY
Carry out the Assay described under Hydrocortisone Cream but prepare solution (2) in the following manner. For ointments containing more than 0.5% w/w of Hydrocortisone, disperse a quantity containing 25 mg of Hydrocortisone in 100 mL of hot hexane, cool and extract with 20 mL of a solution prepared by mixing 3 volumes of methanol with 1 volume of a 15% w/v solution of sodium chloride. Repeat the extraction using a further two 10 mL quantities of the methanolic sodium chloride solution. To the combined extracts add 5 mL of methanol and sufficient water to produce 100 mL, mix and filter through a glass microfibre filter (Whatman GF/C is suitable). For ointments containing 0.5% w/w or less of Hydrocortisone, prepare solution (2) in the same manner as solution (2) above but use a quantity containing 5 mg of Hydrocortisone.
STORAGE
Hydrocortisone Ointment should be protected from light.
