Triamcinolone

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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C₂₁H₂₇FO₆      394.43

Pregna-1,4-diene-3,20-dione, 9-uoro-11,16,17,21-tetrahydroxy-, (11β,16α).

9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione CAS RN: 124-94-7; UNII: 1ZK20VI6TY.

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.

USP REFERENCE STANDARDS (11)

USP Triamcinolone RS

1 Identification

Change to read:

A: Spectroscopic Identification Tests (197). Infrared Spectroscopy: 197K _{(CN 1-May-2020)},

Change to read:

B: Spectroscopic Identification Tests (197), Ultraviolet-Visible Spectroscopy: 1970 _{(CN 1-May-2020)} 

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 (7815): 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.

RESIDUE ON IGNITION (281): 0.5%.

2 Assay

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 x 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(R_u/R_s)

in which C is the concentration, in mg per mL, of USP Triamcinolone RS in the Standard preparation, and R_u and R_s are the peak response ratios of triamcinolone to hydrocortisone obtained from the Assay preparation and the Standard preparation, respectively.