Triamcinolone Tablets

General Notices

Action and use

Glucocorticoid.

Definition

Triamcinolone Tablets contain Triamcinolone.

The tablets comply with the requirements stated under Tablets and with the following requirements.

Content of triamcinolone, C21H27FO6

90.0 to 110.0% of the stated amount.

Identification

A. Dissolve 1 mg of the residue obtained in the test for Related substances in 6 mL of ethanol (96%), add 5 mL of a 1% w/v solution of butylated hydroxytoluene in ethanol (96%) and 5 mL of 1m sodium hydroxide and heat on a water bath under a reflux condenser for 20 minutes. A pinkish lavender colour is produced.
B. In the Assay, the chromatogram obtained with solution (2) shows a peak with the same retention time as the peak due to triamcinolone in the chromatogram obtained with solution (1).

Tests

Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Shake a quantity of the powdered tablets containing 15 mg of Triamcinolone with 15 mL of absolute ethanol for 15 minutes, filter under reduced pressure through fine filter paper (Whatman No. 42 is suitable) and evaporate to dryness using a rotary evaporator. Reserve 1 mg of the residue for test A for Identification. Dissolve the remainder of the residue in 15 mL of methanol (solution A). For solution (1) use solution (A). For solution (2) dilute 4 mL of solution A to 100 mL with methanol. For solution (3) dilute 5 mL of solution (A) to 50 mL with methanol and dilute 5 mL of the resulting solution to 50 mL with the same solvent.

The chromatographic procedure may be carried out using (a) a stainless steel column (20 cm × 4 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Hypersil ODS is suitable), (b) as the mobile phase a mixture of methanol and water, adjusted so that the retention time of triamcinolone is about 5 minutes (a mixture of equal volumes of methanol and water is usually suitable) with a flow rate of 2 mL per minute and (c) a detection wavelength of 238 nm. For solution (3) record the chromatogram for 4 times the retention time of the triamcinolone peak.

The test is not valid unless the column efficiency, determined using the principal peak in the chromatogram obtained with solution (2), is at least 10,000 theoretical plates per metre.

The area of any secondary peak in the chromatogram obtained with solution (1) is not greater than twice the area of the principal peak in the chromatogram obtained with solution (3) (2%) and not more than one such peak has an area greater than that of the principal peak in the chromatogram obtained with solution (3) (1%). The sum of the areas of any such peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (4%).

Assay

Weigh and powder 20 tablets. Prepare a 0.06% w/v solution of testosterone (internal standard) in methanol (solution B) and carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) add 5 mL of solution B to 5 mL of a 0.08% w/v solution of triamcinolone BPCRS in methanol and add 15 mL of methanol (50%). For solution (2) shake a quantity of the powdered tablets containing 2.5 mg of Triamcinolone with 5 mL of methanol and 20 mL of a mixture of 5 volumes of methanol and 3 volumes of water. Shake for 15 minutes, mix with the aid of ultrasound for 10 minutes, centrifuge and use the supernatant liquid. Prepare solution (3) in the same manner as solution (2) but add 5 mL of solution B in place of the 5 mL of methanol.

The chromatographic procedure may be carried out using (a) a stainless steel column (20 cm × 4 mm) packed with end-capped octadecylsilyl silica gel for chromatography (10 µm) (Spherisorb ODS 1 is suitable), (b) a mixture of 70 volumes of methanol, 30 volumes of water and 0.1 volume of glacial acetic acid as the mobile phase with a flow rate of 2 mL per minute and (c) a detection wavelength of 238 nm.

Calculate the content of C21H27FO6 using the declared content of C21H27FO6 in triamcinolone BPCRS.