Sulfasalazine Tablets
»Sulfasalazine Tablets contain not less than 95.0percent and not more than 105.0percent of the labeled amount of sulfasalazine (C18H14N4O5S).
Packaging and storage— Preserve in well-closed containers.
Identification— The visible absorption spectrum of the solution from the Assay preparation,prepared as directed in the Assay,exhibits maxima and minima at the same wavelengths as that of the Standard preparation,prepared as directed in the Assayand concomitantly measured.
Dissolution á711ñ—
Medium: pH7.5phosphate buffer (see under Buffer Solutionsin the section Reagents,Indicators,and Solutions);900mL.
Apparatus 1: 100rpm.
Time: 60minutes.
Procedure— Determine the amount of C18H14N4O5Sdissolved from UVabsorbances at the wavelength of maximum absorbance at about 358nm of filtered portions of the solution under test,suitably diluted with Dissolution Medium,if necessary,in comparison with a Standard solution having a known concentration of USP Sulfasalazine RSin the same Medium.
Tolerances— Not less than 85%(Q)of the labeled amount of C18H14N4O5Sis dissolved in 60minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Assay— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 150mg of sulfasalazine,to a 100-mLvolumetric flask,add 50mLof 0.1Nsodium hydroxide,and mix.Dilute with 0.1Nsodium hydroxide to volume,mix,and filter,discarding the first 20mLof the filtrate.Transfer 5.0mLof the filtrate to a 1000-mLvolumetric flask containing about 750mLof water,mix,add 20.0mLof 0.1Nacetic acid,mix,dilute with water to volume,and mix.Concomitantly determine the absorbances of this solution and of a Standard solution of USP Sulfasalazine RSin the same medium having a known concentration of about 7.5µg per mL,at the wavelength of maximum absorbance at about 359nm,using water as the blank.Calculate the quantity,in mg,of sulfasalazine (C18H14N4O5S)in the portion of Tablets taken by the formula:
20C(AU/AS),
in which Cis the concentration,in µg per mL,of USP Sulfasalazine RSin the Standard solution;and AUand ASare the absorbances of the solution from the Tablets and the Standard solution,respectively.
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1834
Phone Number:1-301-816-8394