Prednisolone Sodium Phosphate Compounded Oral 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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1 DEFINITION

Change to read:

Prednisolone Sodium Phosphate Compounded Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of prednisolone (C₂₁H₂₈O₅).

Prepare Prednisolone Sodium Phosphate Compounded Oral Solution containing (USP 1-May-2022) 10 mg/mL of prednisolone (USP 1-May-2022) as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉).

^a Humco, Texarkana, TX.

^b Perrigo Pharmaceuticals, Allegan, MI.

Pour the weighed prednisolone sodium phosphate powder into a suitable container. Wet the powder with a small amount of Purified Water, and triturate to make a smooth paste. Add the Vehicle to make the contents pourable. Transfer the contents, stepwise and quantitatively, to a calibrated container. Add sufficient Vehicle to bring to final volume. Shake to mix well.

2 ASSAY

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2.1 Procedure

Solution A: Dissolve 2.0 g of 1-pentanesulfonic acid sodium in 1000 mL of water.

Solution B: Mix 980 mL of Solution A with 20 mL of tetrahydrofuran. Adjust with phosphoric acid to a pH of 2.0.

Mobile phase: Methanol and Solution B (45:55)

Standard solution: 0.54 (USP 1-May-2022) mg/mL of prednisolone sodium phosphate, (USP 1-May-2022) prepared from USP Prednisolone Sodium Phosphate RS in Solution B

Sample solution: Shake each bottle of Oral Solution thoroughly. Transfer 1.0 mL of Oral Solution to a 25-mL volumetric flask, dilute with Solution B to volume, and mix well.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 246 nm

Column: 4.6-mm × 25-cm; 5-µm packing L1

Flow rate: 1.0 mL/min

Injection volume: 10 µL

System suitability

Sample: Standard solution

[Note—The retention time for prednisolone is about 11.3 min.]

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0% for replicate injections

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of prednisolone (C₂₁H₂₈O₅) in the portion of Oral Solution taken:

Result = (r_U/r_S) × (C_S/C_U) × (M_r1/M_r2) (USP 1-May-2022) × 100

r_U = peak response of prednisolone sodium phosphate (USP 1-May-2022) from the Sample solution

r_S = peak response of prednisolone sodium phosphate (USP 1-May-2022) from the Standard solution

C_S = concentration of USP Prednisolone Sodium Phosphate RS (USP 1-May-2022) in the Standard solution (mg/mL)

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

M_r1 = molecular weight of prednisolone, 360.44

M_r2 = molecular weight of prednisolone sodium phosphate, 484.39 (USP 1-May-2022)

Acceptance criteria: 90.0%–110.0% 

3 SPECIFIC TESTS

pH 〈791〉: 3.9–4.9

4 ADDITIONAL REQUIREMENTS

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Packaging and Storage: Package in tight, light-resistant containers. Store in a refrigerator (USP 1-May-2022) or at controlled room temperature.

Change to read:

Beyond-Use Date: NMT 90 days after the date on which it was compounded when stored in a refrigerator (USP 1-May-2022) or at controlled room temperature.

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 Prednisolone Sodium Phosphate RS