Fludrocortisone Acetate Compounded Oral Suspension

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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1 DEFINITION

Fludrocortisone Acetate Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of fludrocortisone acetate (C₂₃H₃₁FO₆).

Prepare Fludrocortisone Acetate Compounded Oral Suspension 0.1 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉).

^a Fludrocortisone Acetate 0.1-mg tablets, Teva Pharmaceuticals USA, North Wales, PA.

^b Perrigo, Allegan, MI.

Place the Fludrocortisone Acetate Tablets in a suitable container and triturate to a ne powder. Add a small amount of Ora-Blend, and mix well to form a smooth paste. Add a sufficient amount of Ora-Blend to make the container contents pourable. Transfer the contents stepwise and quantitatively to a calibrated container using the remainder of the Ora-Blend. Add a sufficient amount of Ora-Blend to bring to nal volume. Mix well.

2 ASSAY

Procedure

Mobile phase: Acetonitrile and water (44:56)

Diluent: Acetonitrile, water, and 1 N hydrochloric acid (44:55:1)

Standard stock solution: Transfer 20 mg of USP Fludrocortisone Acetate RS into a 200-mL volumetric ask, add about 10 mL of acetonitrile, and sonicate for 5 min. Dilute with Diluent to volume.

Standard solution: Transfer 0.5 mL of Standard stock solution into a 25-mL volumetric ask, and dilute with Diluent to volume. Sample solution: Transfer 1 mL of Oral Suspension into a 50-mL volumetric ask. Add about 40 mL of Diluent, sonicate for 10 min, and then bring to volume with Diluent. Pass through a polyvinylidene difluoride filter of 0.22-µm pore size, discarding the first 10 drops.

2.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 240 nm

Column: 4.6-mm × 25-cm; 5-µm packing L96

Temperatures

Autosampler: 4°

Column: 25°

Flow rate: 2 mL/min

Injection volume: 100 µL

2.2 System suitability

Sample: Standard solution

[Note—The retention time for fludrocortisone acetate is about 5.6 min.]

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0% for replicate injections

2.3 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of fludrocortisone acetate (C₂₃H₃₁FO₆) in the portion of Oral Suspension taken:

Result = (r_U /r_S ) × (C_S /C_U) × 100

r_U = peak response of fludrocortisone acetate from the Sample solution

r_S = peak response of fludrocortisone acetate from the Standard solution

C_S = concentration of USP Fludrocortisone Acetate RS in the Standard solution (mg/mL)

C_U = nominal concentration of fludrocortisone acetate in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

3 SPECIFIC TESTS

pH 〈791〉: 4.5–5.5

4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Package in tight, light-resistant containers. Store at controlled room temperature or in a refrigerator.

Beyond-Use Date: NMT 90 days from the date on which it was compounded when stored at controlled room temperature or in a refrigerator

Labeling: Label it to indicate that it is to be well shaken before use and to state the Beyond-Use Date.

USP Reference Standards 〈11〉

USP Fludrocortisone Acetate RS _{(USP 1-Dec-2021)}