Triamcinolone Diacetate Oral Solution
» Triamcinolone Diacetate Oral Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of triamcinolone diacetate (C25H31FO8). It contains a suitable preservative.
Packaging and storage— Preserve in tight, light-resistant containers.
Identification— Transfer a quantity of Oral Solution, equivalent to about 10 mg of triamcinolone diacetate, to a separator, and extract with three 10-mL portions of chloroform. Evaporate the combined chloroform extracts on a steam bath to dryness, and dissolve the residue in 5.0 mL of chloroform. Apply 10 µL each of this solution and a solution of USP Triamcinolone Diacetate RS in chloroform containing 2 mg per mL to a suitable thin-layer chromatographic plate (see Chromatography 621) 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 (1 in 2) and heating on a hot plate or under a lamp until spots appear: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
0.005 M Monobasic sodium phosphate solution, Mobile phase, Standard preparation, System suitability preparation, and Chromatographic system— Proceed as directed in the Assay under Triamcinolone Diacetate.
Assay preparation— Quantitatively transfer an accurately measured portion of Oral Solution, equivalent to about 50 mg of triamcinolone diacetate to a 100-mL volumetric flask. Dilute with Mobile phase to volume, and mix. Pipet 4 mL of this solution into a 50-mL volumetric flask, dilute with Mobile phase to volume, and mix. Transfer about 25 mL of this solution to a 50-mL, glass-stoppered centrifuge tube, and centrifuge at high speed for 10 minutes.
Procedure— Proceed as directed for Procedure in the Assay under Triamcinolone Diacetate. Calculate the quantity, in mg, of triamcinolone diacetate (C25H31FO8) in the portion of Oral Solution taken by the formula:
1.25C(rU / rS)
in which C is the concentration, in µg per mL, of USP Triamcinolone Diacetate RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3786
Pharmacopeial Forum: Volume No. 28(2) Page 384
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.