Action and use
Dopamine receptor antagonist; neuroleptic.
Definition
Haloperidol Capsules contain Haloperidol.
The capsules comply with the requirements stated under Capsules and with the following requirements.
Content of haloperidol, C21H23ClFNO2
95.0 to 105.0% of the stated amount.
Identification
A. To a quantity of the contents of the capsules containing 10 mg of Haloperidol add 10 mL of
water and 1 mL of 1
m 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).
B. In the Assay, the principal peak in the chromatogram obtained with solution (1) has the same retention time as the principal peak in the chromatogram obtained with solution (2).
TESTS
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
(1) Shake a quantity of the contents of the capsules containing 10 mg of Haloperidol with 30 mL of
chloroform, disperse with the aid of ultrasound for 15 minutes, 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.
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
Capsules containing less than 2 mg and/or less than 2% w/w of Haloperidol comply with the requirements stated under Capsules using the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
(1) Add sufficient of the mobile phase to the contents of one capsule to produce a solution containing 0.005% w/v of Haloperidol, disperse with the aid of ultrasound for 2 minutes, centrifuge and use the supernatant solution.
(2) 0.005% w/v of haloperidol BPCRS in the mobile phase.
chromatographic conditions
(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 in each capsule using the declared content of C21H23ClFNO2 in haloperidol BPCRS.
Assay
Use the average of the individual results determined in the test for Uniformity of content.