法罗培南中高分子聚合物含量测定方法的建立

Establishment of determination method of high molecular polymer in faropenem

目的用分子排阻色谱法,建立方便快捷的法罗培南中高分子聚合物含量的检测方法。方法采用葡聚糖凝胶G-10柱,用0.01 mol.L-1磷酸盐缓冲液作为流动相A,以水为流动相B,流速2.0 mL·min-1,检测波长为254 nm。结果法罗培南在0.102 1～5.100 5μg范围内有良好的线性关系,相关系数达到0.999。结论该方法灵敏快速,操作简便,重复性好,可用于法罗培南的质量控制。

Objective To establish a convenient and efficient method for the determination of high molecular polymer in faropenem by molecular - exclusion chromatography method. Methods Sephadex G - 10 was adopted with 0.01 mL·min^-1phosphate buffer as mobile phase A, water as mobile phase B at a flow rate of 2.0 mL·min^-1. The detection wavelength was 254 nm. Results The linear range of faropenem was 0. 102 1 - 5. 100 5 μg（ r = 0. 999 ）. Conclusion The method was sensitive, rapid, convenient, accurate and can be used for the quality control of faropenem.