Sulfasalazine Tablets

» Sulfasalazine Tablets contain not less than 95.0 percent and not more than 105.0 percent of the labeled amount of sulfasalazine (C18H14N4O5S).

Packaging and storage— Preserve in well-closed containers.

USP Reference standards

—
USP Sulfasalazine RS.

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 Assay and concomitantly measured.

Dissolution

711

—

Medium: pH 7.5 phosphate buffer (see under Buffer Solutions in the section Reagents, Indicators, and Solutions); 900 mL.

Apparatus 1: 100 rpm.

Time: 60 minutes.

Procedure— Determine the amount of C18H14N4O5S dissolved from UV absorbances at the wavelength of maximum absorbance at about 358 nm 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 RS in the same Medium.

Tolerances— Not less than 85% (Q) of the labeled amount of C18H14N4O5S is dissolved in 60 minutes.

Uniformity of dosage units

905

: meet the requirements.

Assay— Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 150 mg of sulfasalazine, to a 100-mL volumetric flask, add 50 mL of 0.1 N sodium hydroxide, and mix. Dilute with 0.1 N sodium hydroxide to volume, mix, and filter, discarding the first 20 mL of the filtrate. Transfer 5.0 mL of the filtrate to a 1000-mL volumetric flask containing about 750 mL of water, mix, add 20.0 mL of 0.1 N acetic acid, mix, dilute with water to volume, and mix. Concomitantly determine the absorbances of this solution and of a Standard solution of USP Sulfasalazine RS in the same medium having a known concentration of about 7.5 µg per mL, at the wavelength of maximum absorbance at about 359 nm, 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 C is the concentration, in µg per mL, of USP Sulfasalazine RS in the Standard solution; and AU and AS are the absorbances of the solution from the Tablets and the Standard solution, respectively.

Auxiliary Information— Please check for your question in the FAQs before contacting USP.

Topic/Question	Contact	Expert Committee
Monograph	Behnam Davani, Ph.D., M.B.A. Senior Scientist 1-301-816-8394	(MDAA05) Monograph Development-Antivirals and Antimicrobials
Reference Standards	Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org
711	Margareth R.C. Marques, Ph.D. Senior Scientist 1-301-816-8106	(BPC05) Biopharmaceutics05

USP32–NF27 Page 3632

Pharmacopeial Forum: Volume No. 34(3) Page 653