摘要
目的建立厄多司坦原料药中四氢呋喃和异丙醚残留量的测定方法。方法采用顶空毛细管GC法,以Agilent HP-INNOWAX(30m×0.32mm,0.25μm)为分析柱,柱温为程序升温:起始温度70℃,保持3min,以40℃.min-1升温至160℃,保持1min;载气为高纯氮气,柱流速1.0mL.min-1;气化室温度200℃;FID检测器,检测室温度250℃。结果外标法测得四氢呋喃和异丙醚的残留量均远在药典规定的限量以下。结论建立的方法能有效控制盐酸法舒地尔原料药中四氢呋喃和异丙醚的残留量。
OBJECTIVE To develop a headspace gas chromatography method for determination residual organic solvents-Tetrahydrofuran and Isopropylether in erdosteine.METHODS Headspace gas chromatography was used with Angilent INNOWAX capillary column（30m×0.32mm,0.25μm） and temperature programming.The initial column temperature was 70℃ maintained for 3min and then raised（40℃·min-1） to 160℃ for 1min.with nitrogen gas as carrier and FID as detector,The flow of carrier is 1.0mL·min-1,The injection port and detector temperature were 200℃ and 250℃ respectively.RESULTS With external standard method,the solvent-Tetrahydrofuran and Isopropylether residuals in samples were less than the limits of ChP.CONCLUSION The method could be used for the determination of residual solvents in Erdosteine.
出处
《海峡药学》
2013年第3期49-51,共3页
Strait Pharmaceutical Journal
