Oil- and Water-Soluble Vitamins with Minerals Oral Solution Oil- and ...

Chromatographic system— The liquid chromatograph is equipped with a 210-nm detector and a
4.0-mm × 10-cm column that contains packing L1. The flow rate is about 1.0 mL per minute.
Chromatograph 20 µL of the System suitability solution, and record the peak areas as directed for
Procedure: the resolution, R, between panthenol and calcium pantothenate is not less than 1.5; and
the tailing factor for both the calcium pantothenate and the panthenol peaks is not more than 2.0.
Chromatograph the Standard preparation, and record the peak areas as directed for Procedure: the
relative standard deviation for replicate injections is not more than 2%.
Procedure— Separately inject equal volumes (about 20 µL) of the Standard preparation and the
Assay preparation into the chromatograph, record the chromatograms, and measure the peak areas
obtained for calcium pantothenate. Calculate the quantity, in mg, of calcium pantothenate
(C 18 H 32 CaN 2 O 10 ) in each mL of the Oral Solution taken by the formula:
C(L/D)(r U / r S )
in which C is the concentration, in mg per mL, of USP Calcium Pantothenate RS in the Standard
preparation; L is the labeled quantity, in mg per mL, of calcium pantothenate in the Oral Solution
taken; D is the concentration, in mg per mL, of calcium pantothenate in the Assay preparation, on
the basis of the labeled quantity and the extent of dilution; and r U and r S are the peak areas for
calcium pantothenate obtained from the Assay preparation and the Standard preparation,
respectively.
Assay for calcium pantothenate, Method 2— Proceed as directed in the Assay for calcium
pantothenate, Method 2 under Oil- and Water-Soluble Vitamins with Minerals Tablets, except to
read Oral Solution in place of Tablets and to use the following Assay preparation.
Assay preparation— Transfer an accurately measured volume of Oral Solution, equivalent to
about 50 mg of calcium pantothenate, to a 1000-mL volumetric flask containing 500 mL of water.
Add 10 mL of 0.2 N acetic acid and 100 mL of sodium acetate solution (1 in 60), dilute with water
to volume, and filter. Dilute an accurately measured volume of this solution quantitatively, and
stepwise if necessary, with water to obtain a solution having about the same concentration as that
of the Standard preparation.
Assay for dexpanthenol or panthenol, Method 1—
Dilute phosphoric acid, Mobile phase, and Chromatographic system— Proceed as directed in the
Assay for calcium pantothenate, Method 1.