Assay
[NOTEConduct this test promptly with minimum exposure to actinic light.
]
Solvent,Mobile phase,Standard preparation,Resolution solution,and Chromatographic system
Proceed as directed in the
Assayunder
Ubidecarenone Capsules.
Assay preparation
Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed quantity of the powder,equivalent to about 100mg of ubidecarenone,to a 100-mLvolumetric flask,add 60mLof Solvent,and shake by mechanical means for 30minutes.Dilute with Solventto volume,and mix.Centrifuge a portion of this solution,transfer 1.0mLof the supernatant to a 25-mLvolumetric flask,add 2.5mLof a 0.1%solution of anhydrous ferric chloride in alcohol,dilute with alcohol to volume,and mix.
Procedure
Separately inject equal volumes (about 15µL)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 ubidecarenone (C
59H
90O
4)in the portion of Tablets taken by the formula:
2500C(rU/rS),
in which
Cis the concentration,in mg per mL,of
USP Ubidecarenone RSin the
Standard preparation;and
rUand
rSare the peak responses obtained from the
Assay preparationand the
Standard preparation,respectively.