摘要
建立氯雷他定原料药中有机溶剂残留量测定方法。以Agilent FFAP弹性石英毛细管柱(聚乙二醇为固定液,50 m×320μm×0.5μm)为色谱柱,进样口温度为220℃;氢火焰离子化检测器(FID)温度为240℃;柱温为程序升温,初始温度40℃,保持10 min,以20℃.min-1升温至200℃,保持3 min;载气为氮气,流速3 mL.min-1。此色谱条件下被测物均能得到很好的分离,峰面积与浓度呈良好的线性关系,精密度良好,可用于氯雷他定原料药中有机溶剂残留量检测。
GC method for detection of the residual solvents in Loratadine substances was established. A Agilent FFAP capillary column （50 m×320μm×0.5μm） was used with FID detector and nitrogen as the carries gas. The injector temperature was 220 ℃, the detector temperature was 240 ℃, the column temperature rose by program, the initial temperature was 40 ℃ and maintained for 10 rain, then raised to 200 ℃ with a rate of 20 ℃ ·min^-1 and maintained for 3 rain. The flow rate of N2 was 3 mL·min^-1. The method is accurate and reliable . It can be applied in detection of residual solvents in Loratadine substances.
出处
《中国药事》
CAS
2007年第9期759-760,767,共3页
Chinese Pharmaceutical Affairs
