Headspace-Gas Chromatography Method for the Determination of Seven Residual Solvents in Gastrodin Injection
(Objective)To establish a method for the detection of seven residual solvents(methanol,ethanol,propanone,isopropyl alcohol,ethyl acetate,trichloromethane,and pyridine)in gastrodin injection to ensure drug safety.(Methods)Using headspace-gas chromatography with FID detector and Agilent DB-624 column,with temperature programming,to establish the determination method and perform method validation.(Results)All three batches of gastrodin injection samples were found to contain methanol,ethanol,and isopropyl alcohol,while propanone,ethyl acetate,trichloromethane,and pyridine were not detected.(Conclusions)This method has strong specificity and high sensitivity,which is suit-able for the determination of residual solvents in gastrodin injection.The residual solvent control in gastrodin injection is good,and the risk of sol-vent residue is low.
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