Assay
Solution A, Solution B, Mobile phase, System suitability solution, Standard preparation, and Chromatographic system
Proceed as directed in the
Assay under
Amcinonide, except to use a 240-nm detector.
Assay preparation
Dissolve an accurately weighed quantity of Ointment in a suitable volume of a mixture of acetonitrile and chloroform (4:1) by heating in a hot water bath, cooling, and adjusting quantitatively with the same solvent mixture to obtain a solution having a concentration of about 0.2 mg of amcinonide per mL. Cool to room temperature, dilute with acetonitrile to volume, and filter. Transfer 5 mL of this solution to a 50-mL volumetric flask, dilute with Solution B to volume, and mix.
Procedure
Separately inject equal volumes (about 10 µL) of the
Standard preparation and the
Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of amcinonide (C
28H
35FO
7) in the portion of Ointment taken by the formula:
500C(rU / rS),
in which
C is the concentration, in mg per mL, of
USP Amcinonide RS in the
Standard preparation; and
rU and
rS are the peak responses obtained from the
Assay preparation and the
Standard preparation, respectively.