GC法测定他达拉非残留溶剂

Determination of Residual Solvent in Tadalafil by GC

采用气相色谱法及残留溶剂测定法对他达拉非的残留溶剂进行测定.用6%氰丙基苯基-94%二甲基聚硅氧烷为固定液的毛细管柱为色谱柱;柱温在50℃保持5min,再以30℃/min的速率升至240℃,维持5min;检测器为氢火焰离子化检测器,检测器温度为260℃,进样口温度为220℃,载气流速3.0 mL/min,分流比10:1;进样体积1μL,记录色谱图.本方法可以有效、准确地检测出他达拉非的残留溶剂.

The paper aims to determine the residual solvent in tadalafil by gas chromatography and residual solvent determination.The chromatographic column consists of 6%propyl phenyl-94%dimethyl polysiloxane which were utilized as fixed liquid capillary column;the whole process lasted for 5 minutes with the column temperature at 50℃before it rose at a rate from about 30℃/min to 240℃,which lasted for 5 minutes;the detector for hydrogen flame was an ionization detector;the test temperature was 260℃,the sample temperature was 220℃,the carrier gas flow rate was 3.0 mL/min,and the diversion ratio was 10∶1.The sample introduction volume was 1μL and the chromatogram was recorded.It is concluded that this method can effectively detect residual solvents in tadalafil.