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C21H27FO6 394.43

Pregna-1,4-diene-3,20-dione, 9-fluoro-11,16,17,21-tetrahydroxy-, (11,16).
9-Fluoro-11,16,17,21-tetrahydroxypregna-1,4-diene-3,20-dione [124-94-7].
» Triamcinolone contains not less than 97.0 percent and not more than 102.0 percent of C21H27FO6, calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers.
B: Ultraviolet Absorption 197U
Solution: 20 µg per mL.
Medium: methanol.
Absorptivities at 238 nm, calculated on the dried basis, do not differ by more than 3.0%.
Specific rotation 781S: between +65 and +72.
Test solution: 2 mg per mL, in dimethylformamide.
Loss on drying 731 Dry it in vacuum at 60 for 4 hours: it loses not more than 2.0% of its weight.
Mobile phase— Prepare a degassed solution containing about 60 volumes of methanol and 40 volumes of water such that the retention times for triamcinolone and hydrocortisone are about 5 and 10 minutes, respectively.
Internal standard solution— Dissolve hydrocortisone in Mobile phase to obtain a solution having a concentration of about 0.3 mg per mL.
Standard preparation— Transfer about 10 mg of USP Triamcinolone RS, accurately weighed, to a 50-mL volumetric flask, dissolve in Internal standard solution, dilute with the same solvent to volume, and mix.
Assay preparation— Using about 10 mg of Triamcinolone, accurately weighed, prepare as directed under Standard preparation.
Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 254-nm detector and a 3.9-mm × 30-cm column that contains packing L1. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative standard deviation for replicate injections is not more than 2.0%, and the resolution factor between triamcinolone and hydrocortisone is not less than 3.0.
Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph by means of a suitable microsyringe or sampling valve, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of C21H27FO6 in the portion of Triamcinolone taken by the formula:
50C(RU / RS)
in which C is the concentration, in mg per mL, of USP Triamcinolone RS in the Standard preparation, and RU and RS are the peak response ratios of triamcinolone to hydrocortisone 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 3781
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.