Anileridine
;)
4-Piperidinecarboxylic acid,1-[2-(4-aminophenyl)ethyl]-4-phenyl-,ethyl ester.
Ethyl 1-(p-aminophenethyl)-4-phenylisonipecotate [144-14-9].
»Anileridine contains not less than 98.5percent and not more than 101.0percent of C22H28N2O2,calculated on the anhydrous basis.
Packaging and storage—
Preserve in tight,light-resistant containers.Store at room temperature.
Identification—
A:
Dissolve 40mg in 2.3mLof 0.1Nhydrochloric acid in a 100-mLvolumetric flask,dilute with water to volume,and mix(Stock solution).Transfer 4.0mLof this solution to a 100-mLvolumetric flask,and add 25mLof pH7.0Buffer solution.(Prepare the Buffer solutionby dissolving 22.73g of anhydrous dibasic sodium phosphate and 14.52g of monobasic potassium phosphate in water to make 1000mL.Dilute 25mLof the buffer with water to 100mL:the pH,determined potentiometrically,is 7.0±0.05.)Dilute with water to volume,and mix(Solution A).Transfer 20.0mLof the Stock solutionto a 100-mLvolumetric flask,add 25mLof the pH7.0Buffer solution,dilute with water to volume,and mix (Solution B):the UVabsorption spectrum of Solution Aexhibits a maximum at 234±1nm;and the UVabsorption spectrum of Solution Bexhibits a maximum at 285±2nm.The ratio 5A234/A285is about 8.8.
B:
To 5mLof a solution in 0.1Nhydrochloric acid (1in 5000),add 2mLof a solution of p-dimethylaminobenzaldehyde in alcohol (1in 100):a yellow color develops immediately.
Water,Method Iá921ñ:
not more than 1.0%.
Residue on ignition á281ñ:
not more than 0.1%.
Chloride á221ñ—
Dissolve 180mg in a mixture of 1mLof nitric acid and 40mLof water:the solution shows no more chloride than corresponds to 0.10mLof 0.020Nhydrochloric acid (0.040%).
Assay—
Dissolve about 350mg of Anileridine,accurately weighed,in 50mLof glacial acetic acid,add 1drop of crystal violet TS,and titrate with 0.1Nperchloric acid VSto a blue-green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 17.62mg of C22H28N2O2.
Auxiliary Information—
Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 159
Pharmacopeial Forum:Volume No.29(6)Page 1846
Phone Number:1-301-816-8139