Assay
Solution A,Solution B,Mobile phase,System suitability solution,Standard preparation,and Chromatographic system
Proceed as directed in the
Assayunder
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 0.2mg of amcinonide per mL.Cool to room temperature,dilute with acetonitrile to volume,and filter.Transfer 5mLof this solution to a 50-mLvolumetric flask,dilute with Solution Bto volume,and mix.
Procedure
Separately inject equal volumes (about 10µL)of the
Standard preparationand the
Assay preparationinto 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
Cis the concentration,in mg per mL,of
USP Amcinonide RSin the
Standard preparation;and
rUand
rSare the peak responses obtained from the
Assay preparationand the
Standard preparation,respectively.