Medium: water;900

Apparatus 2: 50rpm.

Time: 30minutes.

Procedure— Determine the amount of C21H30O5dissolved from UVabsorbances at the wavelength of maximum absorbance at about 248nm of filtered portions of the solution under test,suitably diluted with Dissolution Medium,if necessary,in comparison with a Standard solution having a known concentration of USP Hydrocortisone RSin the same medium.

Tolerances— Not less than 70%(Q)of the labeled amount of C21H30O5is dissolved in 30minutes.

Procedure for content uniformity—

Mobile solvent ,Internal standard solution,and Standard preparation—Prepare as directed in the Assayunder Hydrocortisone.

Test preparation— Transfer 1Tablet to a suitable container and add about 0.3mLof water directly on the Tablet.Allow the Tablet to stand for about 5minutes.Shake the container to break up the Tablet and sonicate briefly to ensure complete disintegration.Add a few small glass beads and 50.0mLof Internal standard solutionto the container.Shake the container for about 30minutes.Dilute an accurately measured volume of the clear supernatant with a known,accurately measured volume of Internal standard solutionto obtain a final concentration of 0.1mg per mL.Shake the contents of the container to mix,and analyze the clear solution as directed under Procedure.

Procedure— Proceed as directed for Procedurein the Assayunder Hydrocortisone.Calculate the quantity,in mg,of C21H30O5in the Tablet taken by the formula: in which F1is the volume,in mL,of the supernatant aliquot of the solution from the Tablet taken for dilution,and F2is the final volume,in mL,of the Test preparation,and the other terms are as defined for Procedurein the Assayunder Hydrocortisone.

Mobile solvent ,Internal standard solution,and Standard preparation—Prepare as directed in the Assayunder Hydrocortisone.

Assay preparation— Weigh and finely powder not fewer than 10Tablets.Weigh a portion of the powder,equivalent to about 5mg of hydrocortisone,and transfer to a suitable container.Add 50.0mLof Internal standard solution.Shake vigorously for 30minutes,and centrifuge a portion of this mixture.Use the clear supernatant.

Procedure— Proceed as directed for Procedurein the Assayunder Hydrocortisone.Calculate the quantity,in mg,of hydrocortisone (C21H30O5)in the portion of Tablets taken by the formula: in which the terms are as defined therein.