CO-ENZYME Q10

RELATED SUBSTANCES

Liquid chromatography

Test solutionı Dissolve 25.0 mg of the substance to be examined in 25.0 ml of ethanol R by heating at about 50 °C for 2 min. Allow to cool.

Reference solution (a)ı Dissolve 5 mg of ubidecarenone CRS in 5 ml of ethanol R by heating at about 50 °C for 2 min. Allow to cool.

Reference solution (b)ı Dissolve 2 mg of ubidecarenone impurity D CRS in 2 ml of the test solution by heating at about 50 °C for 2 min. Allow to cool. Dilute 1 ml to 50 ml with ethanol R.

Reference solution (c)ı Dilute 1.0 ml of the test solution to 100.0 ml with ethanol R .

Column: ı

ı— size: l = 0.15 m, Ø = 4.6 mm;

ı— stationary phase: octadecylsilyl silica gel for chromatography R (5 μm).

Mobile phaseı ethanol R, methanol R2 (20:80 V/V).

Flow rateı 2 ml/min.

Detectionı Spectrophotometer at 275 nm.

Injectionı 10 μl.

Run timeı 2 times the retention time of ubidecarenone.

Relative retentionı With reference to ubidecarenone (retention time = about 12 min): impurity

D = about 0.67.

System suitabilityı Reference solution (b):

ı— resolution: minimum 6.5 between the peaks due to impurity D and to ubidecarenone.

Limits:

ı— any impurity: not more than half the area of the principal peak in the chromatogram obtained with reference solution (c) (0.5 per cent);

ı— total: not more than the area of the principal peak in the chromatogram obtained with reference solution (c) (1.0 per cent); ı— disregard limit: 0.05 times the area of the principal peak in the chromatogram obtained with reference solution (c) (0.05 per cent).