Hydrocortisone Cream
» Hydrocortisone Cream is Hydrocortisone in a suitable cream base. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of hydrocortisone (C21H30O5).
Packaging and storage— Preserve in tight containers.
Identification— Transfer a quantity of Cream, equivalent to about 5 mg of hydrocortisone, to a flask, add 5 mL of alcohol, and heat on a steam bath for 5 minutes, with frequent shaking. Cool, and filter. Using the filtrate as the test solution, proceed as directed under Thin-layer Chromatographic Identification Test 201.
Microbial enumeration tests 61 and Tests for specified microorganisms 62 It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.
Minimum fill 755: meets the requirements.
Assay—
Mobile phase— Prepare a suitable degassed and filtered solution of water and acetonitrile (about 75:25), such that the retention time of hydrocortisone is about 10 minutes.
Standard preparation— Dissolve an accurately weighed quantity of USP Hydrocortisone RS in methanol to obtain a solution having a known concentration of about 500 µg per mL. Quantitatively dilute 1 volume of this solution with 9 volumes of dilute methanol (1 in 2). The Standard preparation has a final known concentration of about 50 µg per mL. [note—If methanol is used in the final dilution of the Assay preparation, similarly use methanol instead of aqueous methanol in the final dilution of the Standard preparation.]
Assay preparation— Transfer an accurately weighed quantity of Cream, equivalent to about 10 mg of hydrocortisone, to a 150-mL beaker. Add 40 mL of methanol, and heat on a steam bath while stirring to melt and disperse the cream. Cool to room temperature, and filter through glass wool into a 100-mL volumetric flask. Repeat the extraction with two 20-mL portions of methanol, combining the filtrates in the 100-mL volumetric flask. Add methanol to volume, and mix. Quantitatively dilute 1 volume of this solution with an equal volume of water, and filter through a 5 µm membrane filter. If precipitation occurs on dilution with water, and the solution is still cloudy after filtration, dilute the initial test solution with methanol instead of water. Filter this solution through a 5 µm membrane filter.
Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 254-nm detector and a 3.9-mm × 30-cm column that contains packing L1. Adjust operating parameters such that the peak obtained from the Standard preparation is about 0.6 full-scale. Chromatograph five replicate injections of the Standard preparation, and record the peak responses as directed for Procedure: the relative standard deviation is not more than 3.0%.
Procedure— Separately inject equal volumes (about 10 to 25 µL) of the Standard preparation and the Assay preparation into the chromatograph by means of a sampling valve, record the chromatograms, and measure the responses for the major peaks at equivalent retention times. Calculate the quantity, in mg, of C21H30O5 in the portion of Cream taken by the formula:
0.2C(rU / rS)
in which C is the concentration, in µg per mL, of USP Hydrocortisone RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
1-301-816-8143
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
61 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
62 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2573
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.