Hydrocortisone Acetate Injection

Action and use

Corticosteroid.

Definition

Hydrocortisone Acetate Injection is a sterile suspension of Hydrocortisone Acetate in Water for Injections. It is prepared using aseptic technique.

The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.

Content of hydrocortisone acetate, C₂₃H₃₂O₆

95.0 to 105.0% of the stated amount.

Identification

Filter a volume containing 50 mg of Hydrocortisone Acetate through a sintered-glass filter, wash the residue with four 5-mL quantities of water, dissolve in 20 mL of chloroform, wash the chloroform solution with four 10-mL quantities of water, discard the washings, filter the chloroform solution through absorbent cotton and evaporate the filtrate to dryness. The residue complies with the following tests.

A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of hydrocortisone acetate (RS 179).

B. Complies with the test for identification of steroids, Appendix III A, using impregnating solvent I and mobile phase B.

C. Yields the reaction characteristic of acetyl groups, Appendix VI.

Assay

Carry out the method for liquid chromatography, Appendix III D, using the following solutions.

(1) To a volume of the injection containing 50 mg of Hydrocortisone Acetate, add 70 mL of methanol. Shake to produce a clear solution and dilute to 100 mL with methanol. Dilute 10 mL of the resulting solution to 20 mL with water.

(2) Dissolve 25 mg of hydrocortisone acetate BPCRS in 50 mL of methanol and add sufficient water to produce 100 mL.

chromatographic conditions

(a) Use a stainless steel column (10 cm × 5 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS 1 is suitable).

(b) Use isocratic elution and the mobile phase described below.

(d) Use an ambient column temperature.

(e) Use a detection wavelength of 240 nm.

(f) Inject 20 µL of each solution.

mobile phase

50 volumes of methanol and 50 volumes of water.

determination of content

Calculate the content of C₂₃H₃₂O₆ in the injection from the chromatograms obtained using the declared content of C₂₃H₃₂O₆ in hydrocortisone acetate BPCRS.

Storage

Hydrocortisone Acetate Injection should be protected from light.

Labelling

The label states (1) that it is intended for local action; (2) that the container should be gently shaken before a dose is withdrawn.