Prednisolone Tablets
»Prednisolone Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of C21H28O5.
Packaging and storage— Preserve in well-closed containers.
Identification— Pulverize a number of Tablets,equivalent to about 50mg of prednisolone,and digest with 25mLof chloroform for 15minutes.Filter the mixture,and evaporate the filtrate on a steam bath to dryness.Wash the residue with two 10-mLportions of hot solvent hexane,decanting the supernatant each time and discarding it.Digest the residue with 25mLof dehydrated alcohol,warming slightly,for 15minutes.Filter the warm solution,and evaporate the filtrate to a volume of 2to 3mL.Add solvent hexane until the mixture just becomes turbid,chill it to effect crystallization,collect the crystals,and dry them at 60for 1hour:the crystals of prednisolone so obtained respond to Identificationtest Aunder Prednisolone.
Dissolution á711ñ—
Medium: water;900mL.
Apparatus 2: 50rpm.
Time: 30minutes.
Procedure— Determine the amount in solution on filtered portions of the Dissolution Medium,suitably diluted at the wavelength of maximum absorbance at about 246nm,with a suitable spectrophotometer in comparison with a Standard solution having a known concentration of USP Prednisolone RS.An amount of alcohol not to exceed 5%of the total volume of the Standard solution may be used to bring the prednisolone standard into solution prior to dilution with water.
Tolerances— Not less than 70%(Q)of the labeled amount of C21H28O5is dissolved in 30minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Procedure for content uniformity—
Mobile phase,Internal standard solution,Standard preparation,andChromatographic system— Prepare as directed in the Assayunder Prednisolone.
Test preparation— Place 1tablet in a suitable container.Place 0.5mLof water directly on the tablet,and allow to stand until disintegrated (about 30minutes).Gently agitate the container to ensure that the tablet is completely disintegrated.Add 2.0mLof Internal standard solutionfor each mg of labeled tablet strength,and sonicate for about 10minutes.Dilute with a quantity of water-saturated chloroform approximately four times the volume of added Internal standard solution.Add a few glass beads,close the container,and shake vigorously for about 30minutes.Centrifuge,or allow to stand until a clear solution is obtained.Analyze the clear solution as directed under Procedure.
Procedure— Proceed as directed for Procedurein the Assayunder Prednisolone.Calculate the quantity,in mg,of C21H28O5in the Tablet taken by the formula:
(FWS)(RU/RS),
in which Fis the ratio of the volume of the Internal standard solution,in mL,in the Test preparationto the volume,in mL,of the Internal standard solutionin the Standard preparation,WSis the weight,in mg,of USP Prednisolone RStaken for the Standard preparation,and the other terms are as defined therein.
Assay—
Mobile phase,Internal standard solution,andChromatographic system— Prepare as directed in the Assayunder Prednisolone.
Assay preparation— Weigh and finely powder not less than 10Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 10mg of prednisolone,to a 100-mLvolumetric flask.Add 20.0mLof Internal standard solution,and sonicate for 10minutes.Dilute with water-saturated chloroform to volume,and shake for 30minutes.Centrifuge this mixture,and use the clear supernatant.
Procedure— Proceed as directed for Procedurein the Assayunder Prednisolone.Calculate the quantity,in mg,of C21H28O5in the portion of Tablets taken by the formula:
0.1C(RU/RS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1609
Phone Number:1-301-816-8139