USP Monographs: Sulfamethoxazole and Trimethoprim Tablets

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Sulfamethoxazole and Trimethoprim Tablets

Sulfamethoxazole and Trimethoprim Tablets contain not less than 93.0 percent and not more than
107.0 percent of the labeled amounts of sulfamethoxazole (C10H11N3O3S) and trimethoprim
(C14H18N4O3).
Packaging and storage Preserve in well-closed, light-resistant containers.
USP Reference standards

11 USP Trimethoprim RS. USP Sulfamethoxazole RS.

Identification Transfer an amount of finely ground Tablets, equivalent to 4 mg of trimethoprim, to a 10-mL volumetric
flask, add 8 mL of methanol, warm for several minutes on a steam bath with frequent shaking, cool, dilute with methanol to
volume, mix, and centrifuge briefly. Apply 5 L each of this solution, a Standard solution of USP Trimethoprim RS in
methanol containing 0.4 mg per mL, and a Standard solution of USP Sulfamethoxazole RS in methanol containing 2 mg per
mL to separate points about 3 cm from one end of a thin-layer chromatographic plate coated with chromatographic silica
gel mixture. Dry the spots in a current of warm air, and develop the plate with a mixture of chloroform, isopropyl alcohol,
and diethylamine (6:5:1) in a chamber lined with filter paper. Remove the plate, dry, and examine under short-wavelength
UV light: the trimethoprim and sulfamethoxazole spots from the solution under test have the same RF values as the spots
from the corresponding Standard solutions.
Dissolution

711

Medium: 0.1 N hydrochloric acid; 900 mL.

Apparatus 2: 75 rpm.
Time: 60 minutes.
Procedure Determine the amounts of sulfamethoxazole (C10H11N3O3S) and trimethoprim (C14H18N4O3) dissolved,
employing the procedure set forth in the Assay, making any necessary volumetric adjustments (see Chromatography

621

). Calculate the percentage of each active component dissolved by comparison of the peak responses obtained from a
filtered aliquot of the solution under test with the peak responses from the corresponding component obtained from the
Standard preparation.
Tolerances Not less than 70% (Q) of the labeled amounts of C10H11N3O3S and C14H18N4O3 is dissolved in 60 minutes.
Uniformity of dosage units

905 : meet the requirements.

Residual solvents 467 : meet the requirements.

(Official January 1, 2007)
Assay
Mobile phase, Standard preparation, and Chromatographic system Prepare as directed in the Assay under
Sulfamethoxazole and Trimethoprim Oral Suspension.
Assay preparation Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the
powder, equivalent to about 160 mg of sulfamethoxazole, to a 100-mL volumetric flask. Add about 50 mL of methanol and
sonicate, with intermittent shaking, for 5 minutes. Allow to equilibrate to room temperature, dilute with methanol to volume,
mix, and filter. Transfer 5.0 mL of the clear filtrate to a 50-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure Separately inject equal volumes (about 20 L) of the Standard preparation and the Assay preparation into the
chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantities, in
mg, of trimethoprim (C14H18N4O3) and sulfamethoxazole (C10H11N3O3S) in the portion of Tablets taken by the formula:

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USP Monographs: Sulfamethoxazole and Trimethoprim Tablets

2 of 2

http://www.pharmacopeia.cn/v29240/usp29nf24s0_m79300.html

1000C(rU / rS),
in which C is the concentration, in mg per mL, of the appropriate USP Reference Standard in the Standard preparation; and
rU and rS are the responses of the corresponding analyte obtained from the Assay preparation and the Standard
preparation, respectively.
Auxiliary Information Staff Liaison : Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29NF24 Page 2037
Pharmacopeial Forum : Volume No. 29(3) Page 670
Phone Number : 1-301-816-8394

13-06-2015 12:27