The following procedure is applicable
as an aid in verifying the identities of many compendial drug substances
as such and in their respective dosage forms.
Prepare a test solution as directed
in the individual monograph. On a line parallel to and about 2 cm from
the edge of a suitable thin-layer chromatographic plate, coated with a
0.25-mm layer of chromatographic silica gel with a suitable fluorescing
substance (see Chromatography) apply 10 mL
of this solution and 10 mL
of a Standard solution prepared from the USP Reference Standard for the
drug substance being identified, in the same solvent and at the same concentration
as the test solution unless otherwise directed in the individual monograph.
Allow the spots to dry, and develop the chromatogram in a solvent system
consisting of a mixture of chloroform, methanol, and water (180:15:1),
unless otherwise directed in the individual monograph, until the solvent
front has moved about three-fourths of the length of the plate. Remove
the plate from the developing chamber, mark the solvent front, and allow
the solvent to evaporate. Unless otherwise directed in the individual monograph
locate the spots on the plate by examination under short-wave length ultraviolet
light. The Rf value of the principal spot, obtained from the test solution
corresponds to that obtained from the Standard solution.
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