Hydrocortisone Butyrate Cream

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 

Hydrocortisone Butyrate Cream is Hydrocortisone Butyrate in a suitable cream base. It contains NLT 90.0% and NMT 110.0% of the labeled amount of hydrocortisone butyrate (C₂₅H₃₆O₆). 

2 IDENTIFICATION 

The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. 

3 ASSAY 

Procedure 

Mobile phase: Acetonitrile, glacial acetic acid, and water (76:1:124) 

Diluent A: Tetrahydrofuran and glacial acetic acid (1000:1) 

Diluent B: Methanol, water, and glacial acetic acid (500:500:1) 

System suitability stock solution: 0.1 mg/mL each of USP Hydrocortisone Butyrate RS and propyl 4-hydroxybenzoate in Diluent A System suitability solution: 0.02 mg/mL each of USP Hydrocortisone Butyrate RS and propyl 4-hydroxybenzoate in Diluent B, from System suitability stock solution 

Standard stock solution: 0.1 mg/mL of USP Hydrocortisone Butyrate RS in Diluent A 

Standard solution: 0.02 mg/mL of USP Hydrocortisone Butyrate RS in Diluent B, from Standard stock solution 

Sample solution: Nominally 0.02 mg/mL of hydrocortisone butyrate, prepared as follows. Transfer a sufficient quantity of Cream to a volumetric flask of suitable size, add 20% of the ask volume of Diluent A, shake by mechanical means for 30 min, and dilute with Diluent B to volume. 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 254 nm 

Column: 3.0-mm × 10-cm; packing L1 

Flow rate: 1 mL/min 

Injection volume: 5 µL 

System suitability 

Samples: System suitability solution and Standard solution 

[Note—The relative retention times for propyl 4-hydroxybenzoate and hydrocortisone butyrate are 0.7 and 1.0, respectively.] Suitability requirements 

Resolution: NLT 4.0 between propyl 4-hydroxybenzoate and hydrocortisone butyrate, System suitability solution 

Column efficiency: NLT 4000 theoretical plates, Standard solution 

Tailing factor: NMT 1.6, Standard solution 

Relative standard deviation: NMT 2.0%, Standard solution 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of the labeled amount of hydrocortisone butyrate (C₂₅H₃₆O₆) in the portion of Cream taken: 

Result = (r_U/r_S) × (C_S/C_U) × 100 

r_U = peak response from the Sample solution  

r_S = peak response from the Standard solution 

C_S = concentration of USP Hydrocortisone Butyrate RS in the Standard solution (µg/mL) 

C_U = nominal concentration of Hydrocortisone Butyrate in the Sample solution (µg/mL) 

Acceptance criteria: 90.0%–110.0% 

4 PERFORMANCE TESTS 

Minimum Fill 〈755〉: Meets the requirements 

5 SPECIFIC TESTS 

Microbial Enumeration Tests 〈61〉andTests for Specified Microorganisms 〈62〉: It meets the requirements of the tests for the absence of Staphylococcus aureus and Pseudomonas aeruginosa. 

pH 〈791〉: 3.5–4.5 

6 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in well-closed containers. 

USP Reference Standards 〈11〉 

USP Hydrocortisone Butyrate RS