Sulfasalazine Tablets
DEFINITION
Sulfasalazine Tablets contain NLT 95.0% and NMT 105.0% of the labeled quantity of sulfasalazine (C18H14N4O5S).
IDENTIFICATION
• Procedure
Standard solution:
Use the Standard solution, prepared as directed in the Assay.
Sample solution:
Use the Sample solution, prepared as directed in the Assay.
Acceptance criteria:
The visible absorption spectrum of the Sample solution corresponds to that of the Standard solution, as prepared in the Assay.
ASSAY
• Procedure
Sample stock solution:
1.5 mg/mL of sulfasalazine, from finely powdered Tablets (NLT 20 tablets), in 0.1 N sodium hydroxide
Sample solution:
Transfer 5.0 mL of Sample stock solution to a 1000-mL volumetric flask containing 750 mL of water, mix, add 20.0 mL of 0.1 N acetic acid, and dilute with water to volume.
Standard solution:
7.5 µg/mL of USP Sulfasalazine RS in the same medium as the Sample solution
Spectrometric conditions
Mode:
UV-Vis
Analytical wavelength:
Maximum at about 359 nm
Blank:
Water
Analysis
Samples:
Standard solution, Sample solution, and Blank
Concomitantly determine the absorbances of the Samples. Calculate the percentage of C18H14N4O5S in the portion of Tablets taken:
Result = (AU/AS) × (CS/CU) × 100
| AU | = | = absorbance of the Sample solution |
| AS | = | = absorbance of the Standard solution |
| CS | = | = concentration of USP Sulfasalazine RS in the Standard solution (µg/mL) |
| CU | = | = nominal concentration of sulfasalazine in the Sample solution (µg/mL) |
Acceptance criteria:
95.0%–105.0%
PERFORMANCE TESTS
• Dissolution 
711
711
Medium:
pH 7.5 Phosphate Buffer (see Reagents, Indicators, and Solutions—Buffer Solutions); 900 mL
Apparatus 1:
100 rpm
Time:
60 min
Detector:
UV 358 nm
Standard solution:
USP Sulfasalazine RS in Medium
Sample solution:
Pass a portion of the solution under test through a suitable filter. Dilute with Medium, if necessary, to a concentration that is similar to the Standard solution.
Tolerances:
NLT 85% (Q) of the labeled amount of C18H14N4O5S is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers.
• USP Reference Standards 11
11
USP Sulfasalazine RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Leonel M. Santos, Ph.D.
Senior Scientific Liaison 1-301-816-8168 |
(SM12010) Monographs - Small Molecules 1 |
| 711 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4722
Pharmacopeial Forum: Volume No. 35(6) Page 1479