Droperidol Tablets
Action and use
Dopamine receptor antagonist; beta1-adrenoceptor agonist; alpha-adrenoceptor agonist; neuroleptic.
Definition
Droperidol Tablets contain Droperidol.
Content of droperidol, C22H22FN3O2
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.
Calculate the total content of droperidol, C22H22FN3O2, in the medium using the declared content of C22H22FN3O2 in droperidol BPCRS.
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
Mobile phase A1% w/v solution of tetrabutylammonium hydrogen sulfate.
Mobile phase B40 volumes of acetonitrile and 60 volumes of a 1% w/v solution of tetrabutylammonium hydrogen sulfate.
When the chromatogram is recorded under the prescribed conditions, the retention times for benperidol and droperidol are about 6.5 minutes and about 7 minutes respectively. The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to droperidol and benperidol is at least 2.0. If necessary, adjust the final concentration of acetonitrile in the mobile phase or adjust the time programme for the linear gradient.
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) (0.25%);
the sum of the areas of any secondary peaks is not greater than four times the area of the principal peak in the chromatogram obtained with solution (2) (1%).
Disregard any peak obtained with the blank solution and any peak with an area less than 0.4 times the area of the principal peak in the chromatogram obtained with solution (2) (0.1%).
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.
Inject solution (3). When the chromatogram is recorded under the prescribed conditions, the retention times for benperidol and droperidol are about 6.5 minutes and about 7 minutes respectively. The assay is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to droperidol and benperidol is at least 2.0. If necessary, adjust the final concentration of acetonitrile in the mobile phase or adjust the time programme for the linear gradient.
Calculate the content of C22H22FN3O2 in the tablets using the declared content of C22H22FN3O2 in droperidol BPCRS.