顶空气相色谱法测定愈创木酚甘油醚中的残留溶剂  

Determination of Residual Organic Solvents in Guaifenesin by Headspace Gas Chromatography

作　　者：唐立超 郑淑凤 李玲玲 TANG Li-chao;ZHENG Shu-feng;LI Ling-ling(Xiamen Institution for Food and Drug Quality Control,Xiamen 361012,China)

机构地区：[1]厦门市食品药品质量检验研究院,福建厦门361012

出　　处：《海峡药学》2022年第6期30-32,共3页Strait Pharmaceutical Journal

基　　金：国家药品抽验计划项目(国药监药管〔2021〕1号,编号82)。

摘　　要：目的建立愈创木酚甘油醚中6种有机溶剂残留量的顶空气相色谱测定法。方法采用静态顶空毛细管气相色谱法,以安捷伦DB-624(60 m×0.53 mm×3.0μm)为分析柱;载气为5 mL·min^(-1)高纯氮气,程序升温法;进样口温度200℃,FID检测器温度240℃;顶空瓶于80℃保温30 min。结果甲醇、乙醇、丙酮、异丙醇、二氯甲烷和甲苯均与相邻峰分离良好;6种有机溶剂的线性相关系数均大于0.999,精密度、重复性和回收率均符合规定。结论该方法操作简便、结果准确,可用于愈创木酚甘油醚中有机残留溶剂的测定。OBJECTIVE To establish a headspace gas chromatography method for simultaneous determination of six residual solvents in guaifenesin.METHODS Headspace gas chromatography was adopted with DB-624 capillary column(60 m×0.53 mm×3.0μm)and temperature programming.With nitrogen as carrier gas and FID as detector,the flow of carrier was 5 mL·min^(-1).The inlet temperature was 200℃,while detector temperature was 240℃.The sample was preserved heat at 80℃for 30 min.RESUTLS Methyl alcohol,ethyl alcohol,acetone,isopropyl alcohol,dichloromethane and methylbenzene were separated completely.A good linear correlation of these residual solvents were shown within the experimental concentration(r>0.999),respectively.RSD values of precision and repeatability test were all in accordance with Pharmacopoeia requirements;and recovery range were 91.1%~99.6%.CONCLUSION With good accuracy and simple operation,this method can be used for the determination of the residual organic solvents in guaifenesin.

关 键 词：气相色谱法 愈创木酚甘油醚 残留溶剂 

分 类 号：R927[医药卫生—药学]