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DEFINITION
Co-trimoxazole Tablets contain Trimethoprim and Sulfamethoxazole in the
proportions, by weight, 1 part to 5 parts.
The tablets comply with the requirements stated under Tablets and with the
following requirements.
IDENTIFICATION
A. Filter the aqueous layer reserved in the Assay for trimethoprim. Add, drop
wise, sufficient 2M hydrochloric acid to the filtrate to make it just acidic and
extract with 50 mL of ether . Wash the ether layer with 10 mL of water, shake with
5 g of anhydrous sodium sulfate, filter and evaporate the filtrate to dryness using a
rotary evaporator. Dissolve the residue in the minimum volume of a 5% w/v
solution of sodium carbonate, add 1M hydrochloric acid drop wise until
precipitation is complete and filter. Wash the residue sparingly with water and dry
at 105. The infrared absorption spectrum of the residue, Appendix II A, is
concordant with the reference spectrum of sulfamethoxazole (RS 327).
B. To a quantity of the powdered tablets containing 50 mg of Trimethoprim add
30 mL of 0.1M sodium hydroxide and extract with two 50 mL quantities of
chloroform. Wash the combined chloroform extracts with two 10-mL quantities of
0.1M sodium hydroxide and then with 10 mL of water. Shake with 5 g of anhydrous
sodium sulfate, filter and evaporate to dryness using a rotary evaporator. The
CHROMATOGRAPHIC CONDITIONS
(a) Use as the coating silica gel G.
(b) Use the mobile phase as described below.
(c) Apply 5 L of each solution.
(d) Develop the plate to 15 cm.
(e) After removal of the plate, dry in air and spray with dilute potassium
iodobismuthate solution.
MOBILE PHASE
5 volumes of dimethylformamide, 10 volumes of methanol and 100 volumes of
chloroform.
CONFIRMATION
One of the principal spots in the chromatogram obtained with solution (1)
corresponds to the spot in the chromatogram obtained with solution (2) and the
other corresponds to the spot in the chromatogram obtained with solution (3).
ASSAY
Weigh and powder 20 tablets.
For trimethoprim
For sulfamethoxazole