目的建立磺苄西林钠中5种有机溶剂残留量的分离测定方法。方法采用溶液直接进样毛细管气相色谱法,色谱柱为SUPELCOWAX-10的毛细管柱(30 m×0.53 mm,1.0μm),载气为氮气,以水为溶剂,测定了磺苄西林钠原料药中丙酮、异丙醇、乙醇、醋酸丁酯及正丁醇的残留量。结果5种有机溶剂完全分离,在所考察的浓度范围内线性关系良好,其中丙酮的线性范围在6.3～504.0 mg·L^-1(r=0.999 85),异丙醇的线性范围在9.76～490.4 mg·L^-1(r=0.999 95),乙醇的线性范围在7.26～484.0 mg·L^-1(r=0.999 00),醋酸丁酯的线性范围在8.26～471.2 mg·L^-1(r=1.0),正丁醇的线性范围在5.24～508.0 mg·L^-1(r=0.999 95),各残留溶剂的精密度实验RSD均小于5%,平均回收率在99.1%～101.9%之间。结论本实验所建立的方法简便、灵敏、准确,可用于磺苄西林钠中有机溶剂残留量的测定。

OBJECTIVE To develop a method for the determination of five residual solvents in sulbenicillin sodium.METHODS The residual solvents including acetone,isopropanol,ethanol,butyl acetate and butanol were quantitatively determined by capillary GC on SUPELCOWAX-10(30 m×0.53 mm,1.0 μm) column.Water was solvent media,nitrogen was the carrier gas.RESULTS Five residual solvents were completely separated.The linear range of acetone was 6.3-504.0 mg·L-1(r=0.999 85),the linear rangeof isopropanol was 9.76-490.4 mg·L^-1(r=0.999 95),the linear range of ethanol was 7.26-484.0 mg·L-1(r=0.999 00),The linear range of butyl acetate was 8.26-471.2 mg·L^-1(r=1.0)and the linear range of butanol was 5.24-508.0 mg·L-1(r=0.999 95).The RSDs of precision of five residual solvents were less than 5%,the average recovery rates of the preparation were in the range of 99.1%-101.9%.CONCLUSION The method is simple,sensitive,accurate and can be used for the quality control of sulbenicillin sodium.