摘要
目的:建立盐酸噻吩诺啡片有关物质检查的HPLC法。方法:用Phenomenex C_(18)(250 mm×4.6 mm,5μm)色谱柱,以甲醇-0.02 mol·L^(-1)磷酸盐缓冲液(pH=3,含0.2%的三乙胺)(60:40)为流动相,检测波长242 nm,流速1.0 ml·min^(-1)。结果:最低检测限为15μg·L^(-1)。盐酸噻吩诺啡与有关物质分离良好。结论:本法灵敏度高、专属性强,可用于盐酸噻吩诺啡片的有关物质检查。
Objective ： To establish a HPLC method for determination the related substances of thienorphine hydrochloride tablets. Method： The Phenomenex C18 （250mm×4.6mm,5μm） was used,the mobile phose consisted of a mixture of methanol- 0.02 mol· L^-1 phosphate （60：40） buffer solulion [ containing 0.2% triethylarnine （ pH = 3 ） ], the flow rate was 1.0 ml·min^-1, the detection wavelength was 242 nm. Result： The limit of detection was 15 μg·L^-1 for thinenorphine hydrochloride,the thienorphine hydrochloride and related substances completely separated. Conclusion： The method is high sensitive and strong specific, it is suitable for determina- tion the related substances of thienorphine hydrochloride tablets.
出处
《中国药师》
CAS
2010年第1期79-81,共3页
China Pharmacist
