醋氯芬酸 英国药典 2011.doc

Monographs: Medicinal and Pharmaceutical Substances Aceclofenac General Notices (Ph. Eur. monograph 1281) C16H13Cl2NO4354.289796-99-6 Action and use Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory. Ph Eur DEFINITION [[[2-[(2,6-Dichlorophenyl)amino]phenyl]acetyl]oxy]acetic acid. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Practically insoluble in water, freely soluble in acetone, soluble in ethanol (96 per cent). IDENTIFICATION First identificationB. Second identificationA, C. A. Dissolve 50.0 mg in methanol R and dilute to 100.0 ml with the same solvent. Dilute 2.0 ml of the solution to 50.0 ml with methanol R. Examined between 220 nm and 370 nm (2.2.25), the solution shows an absorption maximum at 275 nm. The specific absorbance at the absorption maximum is 320 to 350. B. Infrared absorption spectrophotometry (2.2.24). ComparisonPh. Eur. reference spectrum of aceclofenac. C. Dissolve about 10 mg in 10 ml of ethanol (96 per cent) R. To 1 ml of the solution, add 0.2 ml of a mixture, prepared immediately before use, of equal volumes of a 6 g/l solution of potassium ferricyanide R and a 9 g/l solution of ferric chloride R. Allow to stand protected from light for 5 min. Add 3 ml of a 10.0 g/l solution of hydrochloric acid R. Allow to stand protected from light for 15 min. A blue colour develops and a precipitate is formed. TESTS Related substances Liquid chromatography (2.2.29). Prepare the solutions immediately before use. Test solutionDissolve 50.0 mg of the substance to be examined in a mixture of 30 volumes of mobile phase A and 70 volumes of mobile phase B and dilute to 25.0 ml with the same mixture of solvents. Reference solution (a)Dissolve 21.6 mg of diclofenac sodium CRS (impurity A) in a mixture of 30 volumes of mobile phase