Sephadex G10凝胶色谱法测定磺苄西林钠中的高分子杂质

Determination of high molecular weight impurities in Sulbenicillin sodium by Sephadex G10 system

目的建立测定磺苄西林钠中高分子杂质的方法。方法采用高效液相色谱法,色谱柱为Sephadex G10凝胶柱,流动相A为0.05 mol.L-1的磷酸盐缓冲液(pH7.0)、B为高纯水,流速为1 ml.min-1,检测波长254 nm,柱温为25℃。结果磺苄西林钠中高分子杂质含量小于0.12%。结论所建方法灵敏、准确、简便,可用于磺苄西林钠中高分子杂质的质量控制。

OBJECTIVE To develop a method for the determination of high molecular weight impurities in Sulbenicillin sodium. METHODS HPLC method was adopted. Sephadex G10 gel column and mobile phase A of 0. 05 mol·L^-1 phosphate buffer （pH7. 0） ,and Phase B of super pure water were employed. The flow rate was 1.0 ml·min^-1. The detection wavelength was set at 254 nm, and the column temperature was 25℃. RESULTS The content of the high molecular weight impurities in Sulbenicillin sodium was less than 0. 12%. CONCLUSION The method is simple, rapid and reliable. It can be applied to the quality control of Sulbenicillin sodium.