Identification
Place about 50 mg in a separator, add 20 mL of water and 2 mL of 3 N hydrochloric acid, and extract with 25 mL of chloroform. Filter the extract into a suitable beaker, evaporate on a steam bath to dryness, and dry the residue at 60
for 1 hour: the residue so obtained responds to
Identification test
A under
Prednisolone Hemisuccinate.
Assay
Standard preparation
Dissolve about 64 mg of
USP Prednisolone Hemisuccinate RS, accurately weighed, in about 100 mL of alcohol, add 5.0 mL of water, dilute with alcohol to 200.0 mL, and mix. Dilute 4.0 mL of this solution with alcohol to 100.0 mL, and mix. Pipet 20 mL of the resulting solution into a glass-stoppered, 50-mL conical flask.
Assay preparation
Transfer an accurately weighed portion of Prednisolone Sodium Succinate for Injection, equivalent to about 50 mg of prednisolone, to a 200-mL volumetric flask, dissolve in 5.0 mL of water, add alcohol to volume, and mix. Dilute 4.0 mL of this mixture with alcohol to 100.0 mL, and mix. Pipet 20 mL of the resulting solution into a glass-stoppered, 50-mL conical flask.
Procedure
Proceed as directed under
Assay for Steroids 351. Calculate the quantity, in mg, of C
21H
28O
5 in the portion of Prednisolone Sodium Succinate for Injection taken by the formula:
5C(0.7827)(AU / AS),
in which
C is the concentration, in µg per mL, of
USP Prednisolone Hemisuccinate RS in the
Standard preparation, 0.7827 is the ratio of the molecular weight of prednisolone to that of prednisolone hemisuccinate, and
AU and
AS are the absorbances of the solutions from the
Assay preparation and the
Standard preparation, respectively.