Cortisone Tablets
Action and use
Corticosteroid.
Definition
Cortisone Tablets contain Cortisone Acetate in fine powder.
Content of cortisone acetate, C23H30O6
90.0 to 110.0% of the stated amount.
Identification
Extract a quantity of the powdered tablets containing 0.1 g of Cortisone Acetate with 5 mL of chloroform, filter and evaporate the chloroform. The residue complies with the following tests.
Tests
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared immediately before use.
(g) Continue the chromatography for twice the retention time of the principal peak.
Mix 400 mL of acetonitrile with 550 mL of water, allow to equilibrate and adjust the volume to 1000 mL with water.
Equilibrate the column with the mobile phase at a flow rate of 1 mL per minute for about 30 minutes.
Inject solution (3). When the chromatograms are recorded in the prescribed conditions the retention times are: hydrocortisone acetate, about 10 minutes and cortisone acetate, about 12 minutes.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to hydrocortisone acetate and cortisone acetate is at least 4.2; if necessary, adjust the concentration of acetonitrile in the mobile phase.
In the chromatogram obtained with solution (1):
the area of any secondary peak is not greater than half the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);
the sum of the areas of all the secondary peaks is not greater than 1.5 times the area of the principal peak in the chromatogram obtained with solution (2) (1.5%).
Disregard any peak with an area less than 0.05 times the area of the principal peak in the chromatogram obtained with solution (2) (0.05%).
Dissolution
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.
Calculate the total content of C23H30O6, in the medium from the absorbances obtained and using the declared content of C23H30O6, in cortisone acetate BPCRS.
Assay
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
40 volumes of water and 60 volumes of methanol.
The Assay is not valid unless, in the chromatogram obtained with solution (1), the resolution factor between the peaks due to cortisone acetate and prednisolone is at least 5.0.
Calculate the content of C23H30O6 in the tablets using the declared content of C23H30O6 in cortisone acetate BPCRS.
Storage
Cortisone Tablets should be protected from light.