Action and use
Anticholinergic.
Definition
Dicycloverine Tablets contain Dicycloverine Hydrochloride.
The tablets comply with the requirements stated under Tablets and with the following requirements.
Content of dicycloverine hydrochloride, C19H35NO2,HCl
92.5 to 107.5% of the stated amount.
Identification
A. Extract a quantity of the powdered tablets containing 0.2 g of Dicycloverine Hydrochloride with 20 mL of
chloroform, filter, evaporate the filtrate to dryness, recrystallise the residue from
acetone and dry at 105° for 4 hours. The
infrared absorption spectrum of the residue,
Appendix II A, is concordant with the
reference spectrum of dicycloverine hydrochloride
(RS 098).
B. Shake a quantity of the powdered tablets containing 10 mg of Dicycloverine Hydrochloride with 5 mL of
water and 0.2 mL of 2
m nitric acid, filter and add 0.5 mL of
silver nitrate solution to the filtrate. A white precipitate is produced.
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 0.2 g of Dicycloverine Hydrochloride with 8 mL of
water and 2 mL of 13.5
m ammonia, extract with two 20-mL quantities of
dichloromethane, 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.
(3) 0.1% w/v of each of
dicycloverine hydrochloride BPCRS and
tropicamide BPCRS in
methanol.
chromatographic conditions
(b) Use the mobile phase as described below.
(c) Apply 10 µL of each solution.
(d) Develop the plate to 15 cm.
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%).
Assay
Weigh and powder 20 tablets. To a quantity of the powder containing 30 mg of Dicycloverine Hydrochloride add 20 mL of water and shake. Add 10 mL of 1m sulfuric acid, 1 mL of dimethyl yellow solution and 40 mL of chloroform, shake and titrate with 0.004m sodium dodecyl sulfate VS, shaking vigorously and allowing the layers to separate after each addition, until a permanent orange–pink colour is produced in the chloroform layer. Each mL of 0.004m sodium dodecyl sulfate VS is equivalent to 1.384 mg of C19H35NO2,HCl.