Determation of Residual Levels of Organic Solvents in Sodium Ozagrel by Capillary Gas Chromatography / 中国药房

ABSTRACT

OBJECTIVE: To determine the residual levels of 4 organic solvents(methanol,alcohol,ether and acetone) in the raw material of medicinal sodium ozagrel by capillary gas(GC) chromatography.METHODS: The determination was performed using hydrogen flame ionization detector,AB-CarboWax with nitrogen gas as carrier gas using temperature programming for the column temperature.The sample size was 1 ?L,the temperature of the detector was 280 ℃,the temperature for sample injection was 250 ℃,the flow rate of carrier gas was 1 mL?min-1,and the flow rate of the hydrogen gas was 40 mL?min-1.RESULTS: The linear ranges of methanol was 0.037 5～3 mg?mL-1,alcohol,ether and acetone were 0.062 5～5 mg?mL-1,respectively,their average recoveries ranged from 98.07% to 99.12% with RSD being 0.34%～0.65%.Their lowest detection limits were all less than 3.125 ?g?mL-1,which were undetected for all the samples.CONCLUSIONS: The method is simple,sensitive and accurate,and it can be used for the determination of the residual levels of organic solvents in the raw medicinal of sodium ozagrel.