Sulfasalazine Delayed-Release Tablets
» Sulfasalazine Delayed-Release 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.
Dissolution 711 Proceed as directed for Procedure for Method B under Apparatus 1 and Apparatus 2, Delayed-Release Dosage Forms.
acid stage—
Medium: 0.1 N hydrochloric acid; 900 mL.
Apparatus 1: 100 rpm.
Time: 120 minutes.
At the end of 120 minutes, determine the amount of C18H14N4O5S dissolved by employing the following method.
Mobile phase— Prepare a filtered and degassed mixture of water, isopropanol, acetonitrile, and glacial acetic acid (22:11:7:0.4). Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard solution— Dissolve an accurately weighed quantity of USP Sulfasalazine RS in 0.1 N sodium hydroxide, and dilute quantitatively, and stepwise if necessary, with 0.1 N sodium hydroxide to obtain a solution having a known concentration of about 55.6 µg per mL.
Test solution— Pass about 7 mL of the solution under test through a membrane filter having a 0.45-µm porosity.
Chromatographic system (see Chromatography 621)— The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 25-cm column that contains packing L1. The flow rate is about 1 mL per minute. Chromatograph the Standard solution, and record the peak responses as directed for Procedure: the retention time for sulfasalazine is about 7.7 minutes; and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure— Inject a volume (about 10 µL) of the Standard solution and the Test solution into the chromatograph, and measure the peak responses. Calculate the percentage of C18H14N4O5S dissolved by the formula:
(900CS / LC)(rU / rS)
in which CS is the concentration, in mg per mL, of USP Sulfasalazine RS in the Standard solution; LC is the label claim, in mg; and rU and rS are the peak responses obtained from the Test solution and the Standard solution, respectively.
Tolerances— Not more than 10% of the labeled amount of C18H14N4O5S is dissolved in 120 minutes.
buffer stage—
Medium: pH 7.5 phosphate buffer; 900 mL.
Apparatus 1: 100 rpm.
Time: 60 minutes.
At the end of 60 minutes, determine the amount of C18H14N4O5S dissolved by employing the chromatographic method as described under Acid stage.
Tolerances— Not less than 85% (Q) of the labeled amount of C18H14N4O5S is dissolved in 60 minutes.
Other requirements— Tablets respond to the Identification test and meet the requirements for Uniformity of dosage units and Assay under Sulfasalazine Tablets.
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
(MDAA05) Monograph Development-Antivirals and Antimicrobials
Reference Standards Lili Wang, Technical Services Scientist
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 3633
Pharmacopeial Forum: Volume No. 31(1) Page 185
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.