Gastro-resistant Bisacodyl Tablets
Action and use
Stimulant laxative.
Definition
Gastro-resistant Bisacodyl Tablets contain Bisacodyl. They are made gastro-resistant by enteric coating or by other means.
Content of bisacodyl, C22H19NO4
95.0 to 105.0% of the stated amount.
Identification
TESTS
Dissolution
Comply with the dissolution test for tablets and capsules, Appendix XII B1.
First stage
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
350 volumes of a 0.1% w/v solution of ammonium acetate, adjusted to pH 8.0 with dilute ammonia solution and 650 volumes of acetonitrile.
Calculate the total content of C22H19NO4 in the medium using the declared content of C22H19NO4 in bisacodyl BPCRS.
The amount of bisacodyl released is not more than 5% of the stated amount.
After completion of the first stage, remove the basket from the vessel and dip once into a 100-mL beaker containing 80 mL of water. After the water has drained from the basket, transfer the tablet to Apparatus 2 and carry out the procedure described under Final stage.
Final stage
Dissolve 8.9 g of disodium hydrogen orthophosphate and 10 g of sodium lauryl sulfate in 800 mL of water. Adjust to pH 7.5 with 0.1m hydrochloric acid and dilute to 1000 mL with water (solution A).
The chromatographic conditions described under Dissolution – First stage may be used.
Calculate the total content of C22H19NO4 in the medium using the declared content of C22H19NO4 in bisacodyl BPCRS.
The amount of bisacodyl released is not less than 75% (Q) of the stated amount.
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
A mixture of 4 volumes of glacial acetic acid, 30 volumes of acetonitrile and 66 volumes of water (solution B).
45 volumes of acetonitrile and 55 volumes of 0.025m ammonium formate previously adjusted to pH 5.0 with anhydrous formic acid.
The test is not valid unless the chromatogram obtained with solution (3) closely resembles the reference chromatogram supplied with bisacodyl for system suitability EPCRS.
In the chromatogram obtained with solution (1):
identify any peak corresponding to impurity A and multiply the area of this peak by the following correction factor: 0.7;
the area of any peak corresponding to impurity C is not greater than 1.5 times the area of the principal peak in the chromatogram obtained with solution (2) (1.5%);
the area of any peak corresponding to impurity A is not greater than 0.8 times the area of the principal peak in the chromatogram obtained with solution (2) (0.8%);
the area of any peak corresponding to impurity E is not greater than half the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);
the area of any peak corresponding to impurity F is not greater than 0.3 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%);
the area of any peak corresponding to impurity D is not greater than 0.2 times the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);
the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (5) (0.1%);
the sum of any other secondary peak, excluding impurities A and C, is not more than 0.5%.
Disregard any peak with an area less than half the area of the principal peak in the chromatogram obtained with solution (5) (0.05%).
Assay
Weigh and powder 20 tablets. 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 the chromatogram obtained with solution (3) closely resembles the reference chromatogram supplied with bisacodyl for system suitability EPCRS.
Calculate the total content of bisacodyl, C22H19NO4, in the tablets using the chromatogram obtained and the declared content of C22H19NO4 in bisacodyl BPCRS.
IMPURITIES
The impurities limited by the requirements of this monograph include those listed under Bisacodyl.