Abstract��
OBJECTIVE To establish a capillary GC method for the determination of residual organic solvents����methanol, pentane, ethyl ether,acetone,acetonitrile, dichloromethane, ethyl acetate and isobutyl acetate in rocuronium bromide.METHODS The residual organic solvents were separated on a DB-624 capillary column using temperature programming. FID was used as detector with a temperature of 250 ��,the inlet temperature was 135 ��,and N,N-dimethyl formamide as the solvent. RESULTS The linear ranges of methanol, pentane, ethyl ether,acetone,acetonitrile, dichloromethane, ethyl acetate and isobutyl acetate were 0.06-3.00(r=0.999 9),0.1~5.0(r=0.999 9), 0.1-5.0 (r=1.000 0),0.1-5.0 (r=1.000 0),0.008 2-0.410 0(r=0.999 9),0.012-0.600(r=0.999 9), 0.1-5.0 (r=0.999 9),0.1-5.0 g��L-1 (r=0.999 9), respectively.The average recoveries were ranged from 96.6% to 99.4% with RSD ranged of 0.9%-2.5%.The detection limits were 0.61-1.74 ng.The residual levels for the eight organic solvents in 3 batches samples were all up to the standard stipulated in China Pharmacopeia.CONCLUSION The method is simple,accurate,sensitive and reproducible,it can be used for the determination of the residual organic solvents in rocuronium bromide.
.Determination of Residual Organic Solvents in Rocuronium Bromide by Capillary Gas Chromatography[J] Chinese Pharmaceutical Journal, 2010,V45(7): 553-555