Conduct this test promptly with minimum exposure to actinic light.]
Solvent, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system
Proceed as directed in the Assay
under Ubidecarenone Capsules.
Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed quantity of the powder, equivalent to about 100 mg of ubidecarenone, to a 100-mL volumetric flask, add 60 mL of Solvent, and shake by mechanical means for 30 minutes. Dilute with Solvent to volume, and mix. Centrifuge a portion of this solution, transfer 1.0 mL of the supernatant to a 25-mL volumetric flask, add 2.5 mL of a 0.1% solution of anhydrous ferric chloride in alcohol, dilute with alcohol to volume, and mix.
Separately inject equal volumes (about 15 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 ubidecarenone (C59
) in the portion of Tablets taken by the formula:
2500C(rU / rS),
in which C
is the concentration, in mg per mL, of USP Ubidecarenone RS
in the Standard preparation;
are the peak responses obtained from the Assay preparation
and the Standard preparation,