Hydrocortisone Tablets

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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DEFINITION 

Hydrocortisone Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of hydrocortisone (C₂₁H₃₀O₅). 

1 IDENTIFICATION 

Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197M 

Sample: Powder a number of Tablets, equivalent to 50 mg of hydrocortisone, and digest with 15 mL of solvent hexane for 15 min. Decant the solvent hexane as completely as possible, and extract the residue first with 10 mL of solvent hexane, then with 10 mL of peroxide-free ether in the same manner as before, and discard the extracts. Digest the nal residue with 25 mL of dehydrated alcohol for 15 min with frequent agitation. Filter, and evaporate the alcohol extract on a steam bath to dryness. Use the residue. 

Acceptance criteria: Meet the requirements 

2 ASSAY

Procedure 

Mobile phase: Butyl chloride, water-saturated butyl chloride, tetrahydrofuran, methanol, and glacial acetic acid (95:95:14:7:6) Internal standard solution: 0.06 mg/mL of USP Prednisone RS in water-saturated chloroform 

Standard solution: 0.1 mg/mL of USP Hydrocortisone RS in Internal standard solution 

Sample solution: Nominally 0.1 mg/mL of hydrocortisone from NLT 10 finely powdered Tablets, prepared as follows. Transfer a portion of the powder, equivalent to 5 mg of hydrocortisone, to a suitable container, and add 50.0 mL of the Internal standard solution. Shake vigorously for 30 min, and centrifuge a portion. Use the clear supernatant. 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 254 nm 

Column: 3.9-mm × 30-cm; packing L3 

Flow rate: 0.9 mL/min 

Injection volume: 10 µL 

System suitability 

Sample: Standard solution 

Suitability requirements 

Resolution: NLT 3.0 between hydrocortisone and prednisone 

Relative standard deviation: NMT 2.0% for four replicate injections 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of the labeled amount of hydrocortisone (C₂₁H₃₀O₅) in the portion of Tablets taken: 

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

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

R_S = peak area ratio of hydrocortisone to the internal standard 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% 

3 PERFORMANCE TESTS 

Dissolution 〈711〉 

Medium: Water; 900 mL 

Apparatus 2: 50 rpm 

Time: 30 min 

Standard solution: USP Hydrocortisone RS at a known concentration in Medium 

Sample solution: Pass a portion of the solution under test through a suitable filter. Dilute with Medium if necessary. Instrumental conditions 

(See Ultraviolet-Visible Spectroscopy 〈857〉.) 

Mode: UV 

Analytical wavelength: Maximum absorbance at about 248 nm 

Analysis 

Samples: Standard solution and Sample solution 

Determine the amount of hydrocortisone (C₂₁H₃₀O₅) dissolved. 

Tolerances: NLT 70% (Q) of the labeled amount of hydrocortisone (C₂₁H₃₀O₅) is dissolved. 

Change to read: 

Uniformity of Dosage Units 〈905〉: Meet the requirements 

Procedure for content uniformity 

Mobile phase, Internal standard solution, Standard solution, Chromatographic system, and System suitability: Proceed as directed in the Assay. 

Sample solution: Nominally 0.1 mg/mL of hydrocortisone, prepared as follows. Transfer 1 Tablet to a suitable container, and add 0.3 mL of water directly onto the Tablet. Allow the Tablet to stand for about 5 min. Shake the container to break up the Tablet, and sonicate briefly to ensure complete disintegration. Add a few small glass beads and 50.0 mL of the Internal standard solution to the container. Shake the container for about 30 min. Dilute an accurately measured volume of the clear supernatant with a known, accurately measured volume of the Internal standard solution to obtain the desired concentration. Shake the contents of the container to mix. 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of the labeled amount of hydrocortisone (C₂₁H₃₀O₅) in the Tablet taken: 

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

R_U = peak response ratio of hydrocortisone to the internal standard from the Sample solution

R_S = peak response ratio of hydrocortisone to the internal standard 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) 

4 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in well-closed containers. 

USP Reference Standards 〈11〉 

USP Hydrocortisone RS 

USP Prednisone RS