Assay
Mobile phase
Mix approximately equal volumes of acetonitrile and water, adjusting the ratio of solvents as necessary to achieve acceptable chromatography.
Internal standard solution
Transfer 15 mg of Progesterone to a 50-mL volumetric flask. Dissolve in Mobile phase, dilute with Mobile phase to volume, and mix.
Standard preparation
Transfer about 20 mg of
USP Halcinonide RS, accurately weighed, to a 100-mL volumetric flask, dissolve in
Mobile phase, dilute with
Mobile phase to volume, and mix. Transfer 5.0 mL of this solution to a 50-mL volumetric flask, add 2.0 mL of
Internal standard solution, dilute with
Mobile phase to volume, and mix.
Assay preparation
Transfer an accurately measured quantity of Topical Solution, equivalent to about 1 mg of halcinonide, to a 50-mL volumetric flask, add 2.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.
Chromatographic system and Procedure
Proceed as directed in the
Assay under
Halcinonide Cream. Calculate the quantity, in mg, of C
24H
32ClFO
5 in the portion of Topical Solution taken by the formula:
50C(RU / RS),
in which the terms are as defined therein.