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目的建立测定本芴醇原料药中残留溶剂的顶空毛细管气相色谱法。方法以DB-624毛细管柱(0.53 mm×30 m,3.0μm)为色谱柱,氮气为载气,用FID检测器,测定本芴醇原料药中甲醇、乙醇、乙酸乙酯、甲苯、异丙醇和丙酮的残留量(外标法计算)。结果 6种有机溶剂完全分离,浓度在考察范围内与峰面积具有良好的线性关系,r为0.999 9~1.000 0,平均回收率为99.3%~101.5%,精密度RSD均<10%,最低检出限为0.173~0.396μg·m L-1。结论本法快速、灵敏、准确,能较好地检测本芴醇原料药中有机溶剂残留量,控制产品质量。
OBJECTIVE To establish a capillary gas chromatographic method for the determination of residual solvents in benflumetol APIs. Methods DB-624 capillary column (0.53 mm × 30 μm, 3.0 μm) was used as the column and nitrogen was used as the carrier gas. The contents of methanol, ethanol, ethyl acetate, toluene and isopropyl Alcohol and acetone residues (external standard calculation). Results Six kinds of organic solvents were completely separated. The concentration ranged from 0.999 9 to 1.000 0 with an average recovery of 99.3% ~ 101.5%. The RSDs of precision were all less than 10% The limit was 0.173-0.396 μg · m L-1. Conclusion The method is rapid, sensitive and accurate and can detect the residues of organic solvents in lumefantrine APIs well and control the product quality.