Haloperidol Tablets
Action and use
Dopamine receptor antagonist; neuroleptic.
Definition
Haloperidol Tablets contain Haloperidol.
Content of haloperidol, C21H23ClFNO2
90.0 to 110.0% of the stated amount.
Identification
To a quantity of the powdered tablets containing 10 mg of Haloperidol add 10 mL of water and 1 mL of 1m sodium hydroxide and extract with 10 mL of ether. Filter the ether extract through absorbent cotton, evaporate the filtrate to dryness and dry the residue at 60° at a pressure not exceeding 0.7 kPa. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of haloperidol (RS 173).
TESTS
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
0.5 volume of 13.5m ammonia, 20 volumes of ammonium acetate solution, 20 volumes of water and 60 volumes of 1,4-dioxan.
The test is not valid unless the chromatogram obtained with solution (2) shows a distinct and clearly visible spot.
Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (0.5%).
Uniformity of content
Tablets containing less than 2 mg and/or less than 2% w/w of Haloperidol 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.
45 volumes of acetonitrile and 55 volumes of a 1% w/v solution of ammonium acetate.
Calculate the content of C21H23ClFNO2 using the declared content of C21H23ClFNO2 in haloperidol BPCRS.
Assay
For tablets containing less than 2 mg and/or less than 2% w/w of Haloperidol
Use the average of the individual results determined in the test for Uniformity of content.
For tablets containing 2 mg or more and 2% w/w or more of Haloperidol
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
The chromatographic procedure described under Uniformity of content may be used.
Calculate the content of C21H23ClFNO2 using the declared content of C21H23ClFNO2 in haloperidol BPCRS.