Hydrocortisone Valerate Ointment

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 Valerate Ointment contains NLT 90.0% and NMT 110.0% of the labeled amount of hydrocortisone valerate (C₂₆H₃₈O₆) in a suitable ointment base. 

2 IDENTIFICATION 

Thin-Layer Chromatographic Identification Test 〈201〉 

Samples: Standard solution and Sample solution from the Assay 

Acceptance criteria: Meets the requirements 

3 ASSAY 

Procedure 

Mobile phase: Acetonitrile and water (45:55) 

Internal standard solution: 2.0 mg/mL of ethyl benzoate in methanol 

Standard stock solution: 0.5 mg/mL of USP Hydrocortisone Valerate RS in methanol. Prepare immediately before use. Standard solution: 0.1 mg/mL of USP Hydrocortisone Valerate RS in methanol, prepared as follows. Pipet 2 mL of the Standard stock solution and 2 mL of the Internal standard solution into a 10-mL volumetric ask, and dilute with methanol to volume. 

Sample solution: Nominally 0.1 mg/mL of hydrocortisone valerate, prepared as follows. Transfer a quantity of Ointment, equivalent to 1 mg of hydrocortisone valerate, to a screw-capped tube. Add 8.0 mL of a mixture of methanol and water (3:1), and swirl to disperse. Heat in a steam bath until melted (about 30 s), swirl again, and allow to cool to room temperature. Add 2.0 mL of the Internal standard solution. Centrifuge for 5 min, and filter the supernatant, if necessary, to obtain a clear solution. 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 254 nm 

Column: 3.9-mm × 30-cm; packing L1 

Flow rate: 1 mL/min 

Injection volume: 10 µL 

System suitability 

Sample: Standard solution 

[Note—The relative retention times for ethyl benzoate and hydrocortisone valerate are about 0.8 and 1.0, respectively.] Suitability requirements 

Resolution: NLT 3.0 between ethyl benzoate and hydrocortisone valerate 

Relative standard deviation: NMT 2.0% 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of the labeled amount of hydrocortisone valerate (C₂₆H₃₈O₆) in the portion of Ointment taken: 

Result = (R_U/R_S ) × (C_S /C_U) × 100 

R_U = peak area ratio of the free hydrocortisone valerate to the internal standard from the Sample solution 

R_S = peak area ratio of the free hydrocortisone valerate to the internal standard from the Standard solution 

C_S = concentration of USP Hydrocortisone valerate RS in the Standard solution (mg/mL) 

C_U = nominal concentration of hydrocortisone valerate in the Sample solution (mg/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〉: The total microbial count does not exceed 102 cfu/g. It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa. 

6 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in tight containers, and store at controlled room temperature. 

USP Reference Standards 〈11〉 

USP Hydrocortisone Valerate RS