Identification—
Powder a number of Tablets,equivalent to about 50mg of hydrocortisone,and digest with 15mLof solvent hexane for 15minutes.Decant the solvent hexane as completely as possible,and extract the residue first with 10mLof solvent hexane,then with 10mLof peroxide-free ether in the same manner as before,and discard the extracts.Digest the final residue with 25mLof dehydrated alcohol for 15minutes with frequent agitation,filter,and evaporate the alcohol extract on a steam bath to dryness:the residue so obtained responds to
Identificationtest
Aunder
Hydrocortisone.
Dissolution á711ñ—
Medium:
water;900
Apparatus 2:
50rpm.
Time:
30minutes.
Procedure—
Determine the amount of C
21H
30O
5dissolved 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.
Uniformity of dosage units á905ñ:
meet the requirements.
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 C
21H
30O
5in the Tablet taken by the formula:
50(F2/F1)C(RU/RS),
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.
Assay—
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 (C
21H
30O
5)in the portion of Tablets taken by the formula:
50C(RU/RS),
in which the terms are as defined therein.