Dydrogesterone Tablets

General Notices

Action and use

Progestogen.

Definition

Dydrogesterone Tablets contain Dydrogesterone.

The tablets comply with the requirements stated under Tablets and with the following requirements.

Content of dydrogesterone, C21H28O2

92.5 to 107.5% of the stated amount.

Identification

Extract a quantity of the powdered tablets containing 60 mg of Dydrogesterone with 20 mL of methanol, filter and evaporate the filtrate to dryness. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of dydrogesterone (RS 118).

Tests

Related substances

Carry out the method for gas chromatography, Appendix III B.

(1) Extract a quantity of the powdered tablets containing 20 mg of Dydrogesterone with 50 mL of a 0.020% w/v solution of 1,2,3,4-tetraphenylcyclopenta-1,3-diene (internal standard) in chloroform and filter.
(2) Extract a quantity of the powdered tablets containing 20 mg of Dydrogesterone with 20 mL of chloroform, filter, evaporate to dryness using a rotary evaporator and dissolve the residue in 1 mL of chloroform.
(3) Extract a quantity of the powdered tablets containing 20 mg of Dydrogesterone with 20 mL of a 0.020% w/v solution of 1,2,3,4-tetraphenylcyclopenta-1,3-diene (internal standard) in chloroform, filter, evaporate to dryness using a rotary evaporator and dissolve the residue in 1 mL of chloroform.
(4) Dilute 1 volume of solution (1) to 10 volumes with a 0.020% w/v solution of 1,2,3,4-tetraphenylcyclopenta-1,3-diene (internal standard) in chloroform.
chromatographic conditions
(a) Use a glass column (1.5 m × 2.5 mm) packed with acid-washed, silanised diatomaceous support (100 to 120 mesh) coated with 3% w/w of cyanopropyl methyl silicone fluid (SP-2300 is suitable).
(b) Use helium as the carrier gas at 1.5 mL per minute.
(c) Use isothermal conditions maintained at 240°.
(d) Use an inlet temperature of 240°.
(e) Use a flame ionisation detector at a temperature of 240°.
(f) Inject 1 µL of each solution.
system suitability

The test is not valid unless, in the chromatogram obtained with solution (1), the resolution between the peaks due to dydrogesterone and 1,2,3,4-tetraphenylcyclopenta-1,3-diene is at least 1.5.

limits

In the chromatogram obtained with solution (3), the ratio of the sum of the areas of any secondary peaks to the area of the peak due to the internal standard is not greater than the ratio of the area of the peak due to dydrogesterone to the area of the peak due to the internal standard in the chromatogram obtained with solution (1) (2%).

Disregard any secondary peak with an area less than the area of the peak due to dydrogesterone in the chromatogram obtained with solution (4) (0.2%).

Assay

Weigh and powder 20 tablets. Shake a quantity of the powder containing 10 mg of Dydrogesterone for 15 minutes with 70 mL of methanol, dilute to 200 mL with methanol and filter. Dilute 5 mL of the filtrate to 100 mL with methanol and measure the absorbance of the resulting solution at the maximum at 286 nm, Appendix II B. Calculate the content of C21H28O2 taking 845 as the value of A (1%, 1 cm) at the maximum at 286 nm.

Storage

Dydrogesterone Tablets should be protected from light.