Dissolution 711
Medium:
water; 900 mL.
Apparatus 1:
100 rpm.
Time:
120 minutes.
Procedure
Determine the amount of sennosides dissolved, employing the procedure set forth in the
Assay, making any necessary volumetric adjustments.
Tolerances
Not less than 75% (Q) of the labeled amount of sennosides is dissolved in 120 minutes.
Assay
pH 7.0 phosphate buffer, Borate solution, Sodium dithionite solution, and Standard preparation
Prepare as directed in the
Assay under
Sennosides.
Assay preparation
Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 25 mg of sennosides, to a 25-mL volumetric flask. Add 20 mL of pH 7.0 phosphate buffer, sonicate to dissolve the sennosides, add pH 7.0 phosphate buffer to volume, and mix. Centrifuge the resulting suspension for 15 minutes at 3500 rpm. The supernatant is the Assay preparation.
Procedure
Proceed as directed for
Procedure in the
Assay under
Sennosides. Calculate the quantity, in mg, of sennosides in the portion of Tablets taken by the formula:
25C(IU / IS),
in which
C is the concentration, in mg per mL, of
USP Sennosides RS, corrected for loss on drying, in the
Standard preparation, and
IU and
IS are the fluorescence values observed for the solutions from the
Assay preparation and the
Standard preparation, respectively.