Pimozide Tablets
Action and use
Dopamine receptor antagonist; neuroleptic.
Definition
Pimozide Tablets contain Pimozide.
Content of pimozide, C28H29F2N3O
95.0% to 105.0% of the stated amount.
Identification
Tests
Dissolution
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
The chromatographic conditions described under Related substances may be used.
Calculate the total content of pimozide, C28H29F2N3O, in the medium from the chromatograms obtained and using the declared content of C28H29F2N3O in pimozide BPCRS.
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
Equilibrate the column for at least 10 minutes with the initial mobile phase. The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is at least 5.0.
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) (0.5%);
the sum of the areas of any secondary peaks is not greater than 1.5 times the principal peak in the chromatogram obtained with solution (2) (0.75%).
Uniformity of content
Tablets containing less than 2 mg and/or less than 2% w/w of Pimozide 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.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is at least 5.0.
Calculate the content of C28H29F2N3O in each tablet using the declared content of C28H29F2N3O in pimozide BPCRS.
Assay
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
The chromatographic conditions described under Related substances may be used.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is at least 5.0.
Calculate the content of C28H29F2N3O in the tablets using the declared content of C28H29F2N3O in pimozide BPCRS.
Storage
Pimozide Tablets should be kept protected from light.