Hydrocortisone Lotion

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

DOWNLOAD PDF HERE

1 DEFINITION 

Hydrocortisone Lotion is Hydrocortisone in a suitable aqueous vehicle. It contains NLT 90.0% and NMT 110.0% of the labeled amount of hydrocortisone (C₂₁H₃₀O₅). 

2 IDENTIFICATION 

Thin-Layer Chromatographic Identification Test 〈201〉 

Standard solution: 500 µg/mL of USP Hydrocortisone RS in methanol 

Sample solution: Transfer a quantity of Lotion, nominally equivalent to 5 mg of hydrocortisone, to a separator containing 10 mL of methylene chloride. Shake for 1 min, and allow the layers to separate. Filter the methylene chloride extract onto a suitable chromatographic column that has been packed with 2 g of activated magnesium silicate. Wash the column with 25 mL of methylene chloride with the aid of slight air pressure, discarding the washings, and elute the hydrocortisone with 10 mL of methanol. 

Chromatographic system 

Developing solvent system: Chloroform, methanol, and water (180:15:1) 

Analysis: Proceed as directed in the chapter. 

Acceptance criteria: Meets the requirements 

3 ASSAY 

Procedure 

Mobile phase: Acetonitrile, methanol, and water (21:21:58) 

Standard stock solution: 0.1 mg/mL of USP Hydrocortisone RS in alcohol 

Standard solution: 0.05 mg/mL of USP Hydrocortisone RS from Standard stock solution in water 

System suitability stock solution: 0.05 mg/mL of Propylparaben in alcohol 

System suitability solution: 5 µg/mL of propylparaben and 45 µg/mL of USP Hydrocortisone RS, prepared by diluting 1 mL of the System suitability stock solution with Standard solution to 10 mL 

Sample stock solution: Nominally 0.1 mg/mL of hydrocortisone, prepared as follows. Shake a 100-mL portion of Lotion to ensure homogeneity, and allow to stand until the entrapped air rises. Invert carefully, and transfer a quantity of this Lotion, freshly mixed but free from air bubbles, nominally equivalent to 10 mg of hydrocortisone, to a 40-mL beaker, and add 30 mL of alcohol. Warm gently until the Lotion is dispersed, and cool to room temperature. Filter the mixture into a 100-mL volumetric flask through a pledget of cotton previously moistened with alcohol. Rinse the beaker with two 20-mL portions of alcohol, and collect the washings in the same volumetric flask. Dilute with alcohol to volume. 

Sample solution: Nominally 0.05 mg/mL of hydrocortisone from Sample stock solution in water 

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: 20 µL 

System suitability 

Samples: Standard solution and System suitability solution 

Suitability requirements 

Resolution: NLT 2.0 between propylparaben and hydrocortisone, System suitability solution 

Column efficiency: NLT 1000 theoretical plates for hydrocortisone, System suitability solution 

Tailing factor: NMT 1.2 for hydrocortisone, System suitability solution 

Relative standard deviation: NMT 3.0%, Standard solution 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of the labeled amount of hydrocortisone (C₂₁H₃₀O₅) in the portion of Lotion 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 RS in the Standard solution (mg/mL) 

C_U = nominal concentration of hydrocortisone 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〉: It meets the requirements for absence of Staphylococcus aureus and Pseudomonas aeruginosa. 

6 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in tight containers. 

USP Reference Standards 〈11〉 USP Hydrocortisone RS