摘要
(目的)建立天麻素注射液中7 种残留溶剂(甲醇、三氯甲烷、吡啶、乙醇、丙酮、异丙醇、乙酸乙酯)的检验方法,以确保药物的安全性.(方法)采用顶空-气相色谱法,FID检测器,色谱柱为安捷伦DB-624,程序升温,建立测定方法并进行方法学验证.(结果)天麻素注射液 3 批样品均检出甲醇、乙醇、异丙醇,均未检出丙酮、乙酸乙酯、三氯甲烷、吡啶四个溶剂.(结论)该方法专属性强、灵敏度高,适合于天麻素注射液的残留溶剂测定,天麻素注射液中残留溶剂控制较好,溶剂残留风险较低.
Abstract
(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.
国家科技期刊平台
NSTL
万方数据