Identification—
Powder a number of Tablets, equivalent to about 50 mg of hydrocortisone, and digest with 15 mL of solvent hexane for 15 minutes. Decant the solvent hexane as completely as possible, and extract the residue first with 10 mL of solvent hexane, then with 10 mL of peroxide-free ether in the same manner as before, and discard the extracts. Digest the final residue with 25 mL of dehydrated alcohol for 15 minutes with frequent agitation, filter, and evaporate the alcohol extract on a steam bath to dryness: the residue so obtained responds to
Identification test
A under
Hydrocortisone.
Dissolution 
711
—
Medium:
water; 900
Apparatus 2:
50 rpm.
Time:
30 minutes.
Procedure—
Determine the amount of C
21H
30O
5 dissolved from UV absorbances at the wavelength of maximum absorbance at about 248 nm 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 RS in the same medium.
Tolerances—
Not less than 70% (Q) of the labeled amount of C21H30O5 is dissolved in 30 minutes.
Uniformity of dosage units 905:
meet the requirements.
Procedure for content uniformity—
Mobile solvent
,
Internal standard solution, and
Standard preparation—Prepare as directed in the
Assay under
Hydrocortisone.
Test preparation—
Transfer 1 Tablet to a suitable container and add about 0.3 mL of water directly on the Tablet. Allow the Tablet to stand for about 5 minutes. Shake the container to break up the Tablet and sonicate briefly to ensure complete disintegration. Add a few small glass beads and 50.0 mL of Internal standard solution to the container. Shake the container for about 30 minutes. Dilute an accurately measured volume of the clear supernatant with a known, accurately measured volume of Internal standard solution to obtain a final concentration of 0.1 mg per mL. Shake the contents of the container to mix, and analyze the clear solution as directed under Procedure.
Procedure—
Proceed as directed for
Procedure in the
Assay under
Hydrocortisone. Calculate the quantity, in mg, of C
21H
30O
5 in the Tablet taken by the formula:
50(F2 / F1)C(RU / RS),
in which
F1 is the volume, in mL, of the supernatant aliquot of the solution from the Tablet taken for dilution, and
F2 is the final volume, in mL, of the
Test preparation, and the other terms are as defined for
Procedure in the
Assay under
Hydrocortisone.
Assay—
Mobile solvent
,
Internal standard solution, and
Standard preparation—Prepare as directed in the
Assay under
Hydrocortisone.
Assay preparation—
Weigh and finely powder not fewer than 10 Tablets. Weigh a portion of the powder, equivalent to about 5 mg of hydrocortisone, and transfer to a suitable container. Add 50.0 mL of Internal standard solution. Shake vigorously for 30 minutes, and centrifuge a portion of this mixture. Use the clear supernatant.
Procedure—
Proceed as directed for
Procedure in the
Assay under
Hydrocortisone. Calculate the quantity, in mg, of hydrocortisone (C
21H
30O
5) in the portion of Tablets taken by the formula:
50C(RU / RS),
in which the terms are as defined therein.
