Triamcinolone Diacetate Syrup
(Current title—not to change until June 1,2005)
Monograph title change—to become official June 1,2005
See Triamcinolone Diacetate Oral Solution
»Triamcinolone Diacetate Syrup contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C25H31FO8.It contains a suitable preservative.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— Transfer a quantity of Syrup,equivalent to about 10mg of triamcinolone diacetate,to a separator,and extract with three 10-mLportions of chloroform.Evaporate the combined chloroform extracts on a steam bath to dryness,and dissolve the residue in 5.0mLof chloroform.Apply 10µLeach of this solution and a solution of USP Triamcinolone Diacetate RSin chloroform containing 2mg per mLto a suitable thin-layer chromatographic plate (see Chromatography á621ñ)coated with a 0.25-mm layer of chromatographic silica gel.Allow the spots to dry,and develop the chromatogram in a solvent system consisting of a mixture of ethyl acetate and chloroform (9:1)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.Locate the spots on the plate by lightly spraying with dilute sulfuric acid (1in 2)and heating on a hot plate or under a lamp until spots appear:the RFvalue of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
Assay—
0.005M Monobasic sodium phosphate solution,Mobile phase,Standard preparation,System suitability preparation,and Chromatographic system— Proceed as directed in the Assayunder Triamcinolone Diacetate.
Assay preparation— Quantitatively transfer an accurately measured portion of Syrup,equivalent to about 50mg of triamcinolone diacetate to a 100-mLvolumetric flask.Dilute with Mobile phaseto volume,and mix.Pipet 4mLof this solution into a 50-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.Transfer about 25mLof this solution to a 50-mL,glass-stoppered centrifuge tube,and centrifuge at high speed for 10minutes.
Procedure— Proceed as directed for Procedurein the Assayunder Triamcinolone Diacetate.Calculate the quantity,in mg,of C25H31FO8in the portion of Syrup taken by the formula:
1.25C(rU/rS),
in which Cis the concentration,in µg per mL,of USP Triamcinolone Diacetate RSin the Standard preparation;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1963
Pharmacopeial Forum:Volume No.28(2)Page 384
Phone Number:1-301-816-8139