Edition: BP 2025 (Ph. Eur. 11.6 update)
Dicycloverine Oral Solution
General Notices
Action and use
Anticholinergic.
DEFINITION
Dicycloverine Oral Solution is a solution of Dicycloverine Hydrochloride in a suitable flavoured vehicle. The oral solution complies with the requirements stated under Oral Liquids and with the following requirements.
Content of dicycloverine hydrochloride, C19H35NO2,HCl
90.0 to 110.0% of the stated amount.
IDENTIFICATION
A. To a volume containing 0.1 g of dicycloverine hydrochloride add 10 mL of water and 1 mL of hydrochloric acid, shake with 30 mL of ether and allow to separate. Extract the aqueous layer with 30 mL of chloroform, wash the extract with two 10 mL quantities of water and filter the chloroform solution through anhydrous sodium sulfate. Evaporate the filtrate to dryness, recrystallise the residue from hot acetone and dry the precipitate at 105° for 30 minutes. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of dicycloverine hydrochloride (RS 098). B. Acidify the oral solution with 2M nitric acid and add silver nitrate solution. A white precipitate is produced.
TESTS
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
(1) Add 10 mL of water and 1 mL of hydrochloric acid to a volume containing 0.1 g of dicycloverine hydrochloride, shake with 30 mL of ether and allow to separate. Extract the aqueous layer with 30 mL of dichloromethane, wash the extract with two 10 mL quantities of water, shake with anhydrous sodium sulfate, filter (Whatman 1PS paper is suitable), evaporate the filtrate to dryness and dissolve the residue in 4 mL of dichloromethane.
(2) Dilute 1 volume of solution (1) to 500 volumes with dichloromethane.
(3) 0.1% w/v of each of dicycloverine hydrochloride BPCRS and tropicamide BPCRS in methanol.
CHROMATOGRAPHIC CONDITIONS
(a) Use as the coating silica gel. G
(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 it in a current of warm air and spray with dilute potassium iodobismuthate solution.
MOBILE PHASE
5 volumes of 13.5M ammonia, 10 volumes of ethyl acetate, 10 volumes of water and 75 volumes of propan-1-ol.
SYSTEM SUITABILITY
The test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated spots.
LIMITS
In the chromatogram obtained with solution (1):
any secondary spot is not more intense than the spot in the chromatogram obtained with solution (2) (0.2%). Disregard any spot remaining on the line of application.
ASSAY
To a weighed quantity containing 5 mg of dicycloverine hydrochloride add 5 mL of sulfuric acid (10%) and 2 mL of 0.02M potassium permanganate, mix, allow to stand, add 20 mL of water and 20 mL of chloroform to the decolourised solution and titrate with 0.001M sodium dodecyl sulfate VS using 1 mL of dimethyl yellow solution as indicator. Each mL of 0.001M sodium dodecyl sulfate VS is equivalent to 0.3460 mg of C19H35NO2,HCl. Determine the weight per mL of the oral solution, Appendix V G, and calculate the content of C19H35NO2,HCl, weight in volume.
STORAGE
Dicycloverine Oral Solution should be protected from light.
