Identification—
Extract a quantity of the powdered Tablets, containing about 60 mg of Dydrogesterone, with 20 mL of methanol, filter, and evaporate to dryness: the residue so obtained responds to
Identification test
A under
Dydrogesterone.
Dissolution 
711
—
Medium:
0.3% sodium lauryl sulfate; 500 mL.
Apparatus 2:
100 rpm.
Time:
60 minutes.
Procedure—
Determine the amount of C
21H
28O
2 dissolved from UV absorbances at the wavelength of maximum absorbance at about 295 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 Dydrogesterone RS in the same medium.
Tolerances—
Not less than 75% (Q) of the labeled amount of C21H28O2 is dissolved in 60 minutes.
Assay—
Mobile phase, Standard preparation, System suitability preparation, and Chromatographic system—
Proceed as directed in the
Assay under
Dydrogesterone.
Assay preparation—
Weigh and finely powder not less than 20 Tablets. Transfer a portion of the powder, equivalent to about 20 mg of Dydrogesterone, to a 200-mL volumetric flask, add about 100 mL of Mobile phase, and sonicate for 10 minutes. Cool to room temperature, dilute with Mobile phase to volume, and mix.
Procedure—
Separately inject equal volumes (about 20 µL) of the
Standard preparation and the
Assay preparation into the chromatograph, record the chromatograms, and determine the peak responses by area measurement. Calculate the quantity, in mg, of C
21H
28O
2 in the portion of Tablets taken by the formula:
200C(rU / rS),
in which
C is the concentration, in mg per mL, of
USP Dydrogesterone RS in the
Standard preparation, and
rU and
rS are the Dydrogesterone peak area responses from the
Assay preparation and the
Standard preparation, respectively.
