Fluocinolone Acetonide Topical Solution

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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>>> Fluocinolone Acetonide Topical Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C₂₄H₃₀F₂O₆.

1 Packaging and storage

Preserve in tight containers.

2 USP REFERENCE STANDARDS (11)

USP Fluocinolone Acetonide RS

3 Identification

Transfer a quantity of Topical Solution, equivalent to about 0.5 mg of fluocinolone acetonide, to a separator, add 5 mL of water, and extract with 10 mL of chloroform. Withdraw the chloroform layer into a second separator, wash with 10 mL of water, and dry about 2 mL of the chloroform extract over about 200 mg of anhydrous sodium sulfate: the dried extract responds to the Thin-Layer Chromatographic Identification Test (201), 50 µL of the dried chloroform extract and 50 µL of the Standard solution being applied, and a mixture of chloroform and diethylamine (2:1) being used for development.

MICROBIAL ENUMERATION TESTS (61) and TESTS FOR SPECIFIED MICROORGANISMS (62)-It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.

4 Assay

4.1 Internal standard solution

Dissolve norethindrone in acetonitrile to obtain a solution containing about 200 µg per mL.

4.2 Standard preparation

Dissolve an accurately weighed quantity of USP Fluocinolone Acetonide RS in acetonitrile to obtain a solution having a known concentration of about 200 µg per mL. Transfer 5.0 mL of this solution, 4.0 mL of Internal standard solution, 10 mL of propylene glycol, and about 25 mL of acetonitrile to a 50-mL volumetric flask. Mix, cool to room temperature, dilute with acetonitrile to volume, and mix. The final concentration of USP Fluocinolone Acetonide RS is 20 µg per mL.

4.3 Mobile solvent

Prepare a mixture of water and acetonitrile (3:2). Adjust the ratio as necessary to obtain suitable chromatographic performance.

4.4 Assay preparation

Transfer an accurately measured volume of Topical Solution, equivalent to about 0.5 mg of fluocinolone acetonide, to a 25-mL volumetric flask. Add 2.0 mL of Internal standard solution and 10 mL of acetonitrile. Mix, cool to room temperature, dilute with acetonitrile to volume, and mix.

4.5 Apparatus

Use a suitable high-pressure liquid chromatograph (see Chromatography (621)) of the general type equipped with a detector for monitoring UV absorbance at about 254 nm, and capable of providing a flow rate of about 2 mL per minute for the Mobile solvent. Use a column containing packing L1 so as to provide a resolution factor, R, of at least 2.0 between peaks for norethindrone and fluocinolone acetonide.

4.6 Procedure

Chromatograph equal volumes of the Assay preparation and the Standard preparation, adjusting the system as necessary to obtain peaks of between about 50% and 90% full-scale. Calculate the quantity, in mg, of C₂₄H₃₀F₂O₆ in each mL of the Topical Solution taken by the formula:

0.025(C/V)(R_U/R_S)

in which C is the concentration, in µg per mL, of USP Fluocinolone Acetonide RS in the Standard preparation; V is the volume, in mL, of Solution taken; and R_U and R_S are the ratios of the areas of the fluocinolone acetonide peak to the internal standard peak obtained from the Assay preparation and the Standard preparation, respectively.