Dispersible Aspirin Tablets
Action and use
Salicylate; non-selective cyclo-oxygenase inhibitor; antipyretic; analgesic; anti-inflammatory.
Definition
Dispersible Aspirin Tablets contain Aspirin in a suitable dispersible basis.
Content of aspirin, C9H8O4
95.0 to 105.0% of the stated amount.
Identification
Shake a quantity of the powdered tablets containing 0.5 g of Aspirin with 20 mL of absolute ethanol, filter (Whatman GF/C is suitable), evaporate the filtrate and dry the residue at 60° for 1 hour. The infrared absorption spectrum of the residue, is concordant with the reference spectrum of aspirin (RS 483).
Tests
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared immediately before use.
2 volumes of orthophosphoric acid, 400 volumes of acetonitrile and 600 volumes of water.
When the chromatograms are recorded under the prescribed conditions, the retentions relative to aspirin (retention time about 5 minutes) are: impurity A, about 0.6; impurity B, about 0.7, impurity C, about 1.4 and impurity F, about 8.0.
The test is not valid unless, in the chromatogram obtained with solution (4) the resolution between the peaks due to aspirin and impurity C is at least 6.0.
In the chromatogram obtained with solution (1):
the area of any peak corresponding to impurity C is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (3%);
the area of any other secondary peak is not greater than half the area of the principal peak in the chromatogram obtained with solution (2) (0.1%);
the sum of the areas of any other secondary peaks is not greater than 5 times the area of the principal peak in the chromatogram obtained with solution (2) (1.0%).
Disregard any peak with an area less than 0.25 times the area of the principal peak in the chromatogram obtained with solution (2) (0.05%).
Assay
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared immediately before use.
The chromatographic procedure described under Related substances may be used.
The test is not valid unless, in the chromatogram obtained with solution (3) the resolution between the peaks due to aspirin and impurity C is at least 6.0.
Calculate the content of C9H8O4 in the tablets from the chromatograms obtained using the declared content of C9H8O4 in aspirin BPCRS.
Labelling
The label states that the tablets contain Aspirin, unless this word appears in the name of the tablets (this requirement does not apply in countries where exclusive proprietary rights in the name Aspirin are claimed).
When Dispersible Aspirin Tablets are prescribed or demanded, no strength being stated, tablets containing 300 mg shall be dispensed or supplied.
When soluble aspirin tablets are prescribed, Dispersible Aspirin Tablets shall be dispensed.
IMPURITIES
The impurities limited by the requirements of this monograph include those listed under Aspirin.