气相色谱法测定雷洛昔芬原料药中有机溶剂残留量

Determination of the organic solvent residue in raloxifence by GC

目的 探讨雷洛昔芬原料药中残留溶剂甲醇、乙醇、乙酸乙酯、三氯甲烷含量的测定方法。方法 采用气相色谱法。结果 甲醇在 2 1 9 78～ 732 6 0mg·L-1 浓度范围内 ,回归方程 ^Y =0 0 0 0 5 1 4 5 7X +43 1 6 ,r =0 9995 ;乙醇在 373 31～ 1 2 4 4 2mg·L-1 的浓度范围内 ,回归方程为 ^Y =0 0 0 0 3887X +73 4 1 ,r=0 9995 ;乙酸乙酯在 372 0 8～ 1 2 4 0 2mg·L-1 的浓度范围内 ,回归方程为 ^Y=0 0 0 0 4 4 2 5X +73 0 8,r =0 9995 ;三氯甲烷在 4 4 76～ 1 4 92 0mg·L-1 的浓度范围内 ,回归方程 ^Y =0 0 0 0 2 85 9X +0 4 3,r =0 9980。结果表明 :以上各浓度范围内 ,线性关系良好。结论 气相色谱法简便易行 。

Aim A GC method was used to determine the residual organic solvent of the methanol,ethanol,ethyl ethanoate and trichoromthane in raloxifence.Methods GC method.Result A good linear correlation were obtained over the range of 219 78～732 60 mg·ml -1 for methanol and 373 31～1244 2 mg·L -1 for ethanol and 372 08～1240 2 mg·L -1 for ethyl ethanoate and 4 476～14 920 mg·L -1 for trichoromethane.The regression equations were =0 00051457 X +43 16, r =0 9995 for methanol and =0 0003887 X +73 41, r =0 9995 for ethanol and =0 0004425 X +73 08, r =0 9995 for ethyl ethanoate and =0 0002859 X +0 043, r =0 9980 for trichloromethane .Conclusion The method was easily operative and accurate for precise determination.