Glyceryl Trinitrate Tablets
Definition
Glyceryl Trinitrate Tablets are sublingual tablets made with Mannitol as the basis and may be prepared by adding Glyceryl Trinitrate Solution of an appropriate concentration to dried granules of Mannitol, mixing intimately, drying at a temperature not exceeding 50° or without heating for not more than 4 hours and compressing.
Content of glyceryl trinitrate, C3H5N3O9
85.0 to 115.0% of the stated amount.
Identification
The principal spot in the chromatogram obtained with solution (1) corresponds in position and colour to that in the chromatogram obtained with solution (2).
Tests
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
40 volumes of acetonitrile and 60 volumes of water.
The test is not valid unless the chromatogram obtained with solution (3) resembles the reference chromatogram supplied with glyceryl trinitrate solution BPCRS in that it shows a principal peak due to glyceryl trinitrate and two clearly separated peaks due to the dinitrate impurities with retention times relative to glyceryl trinitrate of approximately 0.5.
In the chromatogram obtained with solution (1):
the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%);
the sum of the areas of any such peaks is not greater than three times the area of the principal peak in the chromatogram obtained with solution (2) (3%).
Disregard any peak with an area less than 0.1 times the area of the principal peak in the chromatogram obtained with solution (2) (0.1%).
Uniformity of content
Tablets containing less than 2 mg and/or less than 2% w/w of glyceryl trinitrate comply with the requirements stated under Tablets using the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
The chromatographic conditions described under Related substances may be used, with the exception of the run time.
The test is not valid unless the chromatogram obtained with solution (3) resembles the reference chromatogram supplied with glyceryl trinitrate solution BPCRS in that it shows a principal peak due to glyceryl trinitrate and two clearly separated peaks due to the dinitrate impurities with retention times relative to glyceryl trinitrate of approximately 0.5.
Calculate the content of C3H5N3O9 in each tablet from the chromatograms obtained and using the declared content of C3H5N3O9 in glyceryl trinitrate solution BPCRS.
Assay
Use the average of the individual results determined in the test for Uniformity of content.
Storage
Glyceryl Trinitrate Tablets should be protected from light and stored in a glass container closed by means of a screw closure lined with aluminium or tin foil; additional packing that absorbs glyceryl trinitrate should be avoided. Glyceryl Trinitrate Tablets should be issued for patients in containers of not more than 100 tablets.