凝胶色谱法测定苯唑西林钠片聚合物的含量

目的：建立凝胶色谱法（SEC）测定苯唑西林钠片聚合物。方法：采用依利特色谱柱（填料：Sephadex G-10；尺寸：10.0mm＆#215;300mm）；流动相A为pH7.0的0.01mol·mL^-1磷酸盐缓冲液0.01mol·mL^-1磷酸氢二钠溶液-0.01mol·mL^-1磷酸二氢钠溶液（61：39）]，流动相B为超纯水；流速1.0mL·min^-1；检测波长为254nm；进样量为200μL；以苯唑西林对照品进行测定，按外标法定量。结果：苯唑西林的线性范围1.8051μg·mL^-1～18.0511μg·mL^-1（r=1.0000），定量限为1＆#215;10-3mg·mL^-1，重复性良好（RSD为0.24%，n=6）；供试品测定的线性范围为1.1252mg·mL^-1～11.4653 mg·mL^-1（r=0.9997），重复性良好（RSD为2.17%， n=5）。结论：该方法能够较好地分离苯唑西林钠和聚合物，可用于苯唑西林钠片聚合物的检验。

Determination of the Polymers in Oxacillin Sodium Tables by SEC

Objective：To establish a size exclusion chromatography （SEC） method for the determination of the polymers in oxacili-in sodium tables. Methods：A Sephadex G-10 gelcolumn （10.0mm＆#215;300mm） was used.The mobile phase A was 0.01mol·mL^-1 phos-phate buffer solution （pH=7.0）, and B was water.The flow rate was 1.0mL·min^-1, the detection wavelength was at 254nm, the injection volume was 200μL and the concentration of polymers was quantified by external standard method. Oxacllin was used as substitute ref-erence substance. Results：For HPSEC method, the calibration curves were linera in the range of 1.8051μg·mL^-1-18.0511μg·mL^-1for oxillin（r=1.0000）, and the limit of quantitation was 1＆#215;10-3mg·mL^-1,The RSD for replicate injection of reference solution was 0.24%（n=5）, and the calibratin curves were linear in the range of 1.1252mg·mL^-1~11.4653 mg·mL^-1 for oxacillin （r=0.9997）, and the repeat-ability for 5 measurement results was 2.17%（n=5）. Conclusition：This method can be used in separating the polymers from oxacillin preferably, and is suitable for controlling the quality of this drug.