Determination of Benzyl Bromide in Donepezil Hydrochloride Tablets by GC-MS
Objective To establish a GC-MS method for the determination of benzyl bromide in Donepezil Hydrochloride Tablets.Methods An Agilent DB-624(6%cyanide propylbenzene-94%dimethylsiloxane copolymer,60 m×0.25 mm,1.40 μm)was used for separating the analytes by programmed heating.Injection port temperature:210℃;Injection volume:1 μl.The flow rate of the chromatographic column is 1.1 ml/min.Mass spectrometry conditions:EI source;ion source temperature:220 C;Solvent delay:8.0 min,electron energy:70 eV.Results The concentration of Benzyl bromide is 10.11～505.48 ng/ml,and the linear relationship is good(r2＞0.99).The range of sample recovery rate(n=3)is 86.53%～111.66%,with a detection limit of 3.03 ng/ml and a quantification limit of 10.11 ng/ml.Conclusion This method has strong specificity,high sensitivity and good stability,and can accurately quantify the genotoxic impurity benzyl bromide in Donepezil hydrochloride tablets,providing method support for the determination of genotoxic impurity benzyl bromide in Donepezil hydrochloride tablets.
国家科技期刊平台
NSTL
万方数据
