Haloperidol Tablets

General Notices

Action and use

Dopamine receptor antagonist; neuroleptic.

Definition

Haloperidol Tablets contain Haloperidol.

The tablets comply with the requirements stated under Tablets and with the following requirements.

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.

(1) Shake a quantity of the powdered tablets containing 10 mg of Haloperidol with 10 mL of chloroform, filter, evaporate the filtrate to dryness and dissolve the residue in 1 mL of chloroform.
(2) Dilute 1 volume of solution (1) to 200 volumes with chloroform.
chromatographic conditions
(a) Use as the coating a suitable silanised silica gel containing a fluorescent indicator with an optimal intensity at 254 nm (Merck silanised silica gel 60 F254 plates are suitable).
(b) Use the mobile phase as described below.
(c) Apply 10 µL of each solution.
(d) Develop the plate to 15 cm.
(e) After removal of the plate, dry in a current of warm air for 15 minutes and examine under ultraviolet light (254 nm).
mobile phase

0.5 volume of 13.5m ammonia, 20 volumes of ammonium acetate solution, 20 volumes of water and 60 volumes of 1,4-dioxan.

system suitability

The test is not valid unless the chromatogram obtained with solution (2) shows a distinct and clearly visible spot.

limits

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.

(1) Place one tablet in 10 mL of the mobile phase, disperse with the aid of ultrasound for 2 minutes and centrifuge. If necessary, dilute the supernatant liquid with the mobile phase to produce a solution containing 0.005% w/v of Haloperidol.
(2) 0.005% w/v of haloperidol BPCRS in the mobile phase.
chromatographic conditions
(a) Use a stainless steel column (15 cm × 5 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Hypersil ODS is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 2 mL per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 247 nm.
(f) Inject 20 µL of each solution.
mobile phase

45 volumes of acetonitrile and 55 volumes of a 1% w/v solution of ammonium acetate.

determination of content

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.

(1) Add 60 mL of the mobile phase to a quantity of the powdered tablets containing 20 mg of Haloperidol, disperse with the aid of ultrasound for 2 minutes, add sufficient mobile phase to produce 100 mL, mix and filter.
(2) 0.020% w/v of haloperidol BPCRS in the mobile phase.
chromatographic conditions

The chromatographic procedure described under Uniformity of content may be used.

determination of content

Calculate the content of C21H23ClFNO2 using the declared content of C21H23ClFNO2 in haloperidol BPCRS.