顶空毛细管气相色谱法测定瑞舒伐他汀钙的残留溶剂

Determination of Residual Organic Solvents in Rosuvastatin Calcium by Headspace Gas Chromatography

目的：建立瑞舒伐他汀钙残留有机溶剂的检测方法。方法：采用顶空毛细管气相色谱法;色谱柱为DB-624（30 m×0.53 mm×3μm）,FID检测器,测定瑞舒伐他汀钙中残留的甲醇、乙醚和丙酮。结果：各被测溶剂均能良好分离,各溶剂线性关系良好,精密度RSD均小于10%,平均回收率为95%~105%之间。结论：该法适用于瑞舒伐他汀钙原料药的残留溶剂测定。

Objective： A method for the determination of residual solvent in Rosuvastatin Calcium was established, Methods： The GC was used. DB-624 （30 m×0.53 mm×3 μm） column and FID detector were used. Make an quantitative analysis of the residual solvent in Rosuvastatin Calcium including methanol, diethyl ether and acetone. Results： Each solvent could be completely separated in chromatogram, and the calibration curves of each solvent had good linear relationship, the RSD of precision was less than 10 %, the average recovery was in the range of 95 %-105 %. Conclusion： it can be applied in detection of residual solvents in Rosuvastatin Calcium.