Procyclidine Tablets

General Notices

Action and use

Anticholinergic.

Definition

Procyclidine Tablets contain Procyclidine Hydrochloride.

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

Content of procyclidine hydrochloride, C19H29NO,HCl

90.0 to 110.0% of the stated amount.

Identification

A. Disperse a quantity of the powdered tablets containing 25 mg of Procyclidine Hydrochloride in 10 mL of water, shake with 20 mL of ether and discard the ether layer. Make the aqueous layer alkaline with 2m sodium hydroxide and extract with two 20-mL quantities of ether. Wash the combined ether extracts with two 10-mL quantities of water, dry by shaking with anhydrous sodium sulfate, filter and evaporate the filtrate to dryness. If necessary, induce crystallisation by scratching with a glass rod. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of procyclidine (RS 291).
B. The powdered tablets yield the reactions characteristic of chlorides, Appendix VI.

Related substances

Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions in chloroform.

(1) Shake a quantity of the powdered tablets containing 25 mg of Procyclidine Hydrochloride with 5 mL of chloroform and filter.
(2) Dilute 1 volume of solution (1) to 200 volumes.
(3) 0.001% w/v of 1-phenyl-3-pyrrolidinopropan-1-one hydrochloride BPCRS.
chromatographic conditions
(a) Use as the coating silica gel GF254.
(b) Use the mobile phase as described below.
(c) Apply 20 µL of each solution.
(d) Develop the plate to 15 cm.
(e) After removal of the plate, dry at 105° for 15 minutes and examine under ultraviolet light (254 nm) (first examination). Spray the plate with dilute potassium iodobismuthate solution (second examination).
mobile phase

1 volume of 13.5m ammonia and 100 volumes of ether.

limits

In the first examination:

any spot corresponding to 1-phenyl-3-pyrrolidinopropan-1-one in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (3) (0.2%).

In the second examination:

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%).

Disregard any spot due to excipients on the line of application.

Assay

Weigh and finely powder 20 tablets. Record second-derivative ultraviolet absorption spectra of the following solutions, Appendix II B, in the range 220 to 280 nm. For solution (1) add 80 mL of 0.1m hydrochloric acid to a quantity of the powdered tablets containing 25 mg of Procyclidine Hydrochloride, mix with the aid of ultrasound for 15 minutes, cool, dilute to 100 mL with 0.1m hydrochloric acid and filter through a glass fibre paper having a maximum pore size of 0.7 µm (Whatman GF/F paper is suitable) discarding the first 10 mL of filtrate. Solution (2) contains 0.025% w/v of procyclidine hydrochloride BPCRS in 0.1m hydrochloric acid.

For each solution measure the amplitude from the largest trough at about 257 nm to the largest peak at about 254 nm. Calculate the content of C19H29NO,HCl using the declared content of C19H29NO,HCl in procyclidine hydrochloride BPCRS.