Sumatriptan Tablets
Action and use
Serotonin 5HT1 receptor agonist; treatment of migraine.
Definition
Sumatriptan Tablets contain Sumatriptan Succinate.
Content of sumatriptan, C14H21N3O2S
95.0 to 105.0% of the stated amount.
Identification
Add 10 mL of methanol to a quantity of powdered tablets containing the equivalent of 70 mg of sumatriptan, mix with the aid of ultrasound for 5 minutes, filter through a 0.45-µm PTFE filter, evaporate the filtrate and dry under reduced pressure for 1 hour. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of sumatriptan succinate (RS 413).
Tests
Dissolution
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.
Calculate the total content of C14H21N3O2S, in the medium from the absorbances obtained and using the declared content of C14H21N3O2S,C4H6O4 in sumatriptan succinate BPCRS. 1 mg of C14H21N3O2S,C4H6O4 is equivalent to 0.714 mg of C14H21N3O2S.
Impurities A and H
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
10 volumes of 10m ammonium acetate and 90 volumes of methanol.
The test is not valid unless, using solution (3):
the chromatogram resembles that supplied with sumatriptan for system suitability EPCRS;
the resolution between impurity A and sumatriptan is at least 1.5.
Identify any peak in the chromatogram obtained with solution (1) due to impurity A using the chromatogram obtained with solution (3). Multiply the area of any peak corresponding to impurity A by a correction factor of 0.5.
In the chromatogram obtained with solution (1):
the area of any peak corresponding to impurity A is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.75%);
the area of any peak corresponding to impurity H is not greater than 0.4 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%).
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
25 volumes of acetonitrile and 75 volumes of a solution containing 0.97 g of dibutylamine, 0.735 g of orthophosphoric acid and 2.93 g of sodium dihydrogen orthophosphate in 750 mL of water, adjusted to pH 7.5 with 10m sodium hydroxide and diluted to 1000 mL with water.
The test is not valid unless in solution (3):
the chromatogram resembles that supplied with sumatriptan impurity mixture EPCRS;
the resolution between impurity C and sumatriptan is at least 1.5.
In the chromatogram obtained with solution (1):
the area of any peaks corresponding to impurities B, C or D is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.75%);
the area of any other secondary peak is not greater than area of the principal peak in the chromatogram obtained with solution (2) (0.3%).
Disregard any peak with an area less than a third of the area of the principal peak in the chromatogram obtained with solution (2) (0.1%).
The total impurity content in the test for Impurities A and H and the test for Related substances is not greater than 2.0%.
Assay
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
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 sumatriptan and impurity C is at least 1.5.
Calculate the content of C14H21N3O2S in the tablets using the declared content of C14H21N3O2S,C4H6O4 in sumatriptan succinate BPCRS. 1 mg of C14H21N3O2S,C4H6O4 is equivalent to 0.714 mg of C14H21N3O2S.
Labelling
The quantity of the active ingredient is stated in terms of the equivalent amount of sumatriptan.
Impurities
The impurities limited by the requirements of this monograph include those listed under Sumatriptan Succinate.