注射用头孢拉定有关物质Ⅱ考察方法研究

Determination of related substances Ⅱ in cefradine for injection by gel permeation chromatography

目的建立测定注射用头孢拉定中有关物质Ⅱ的高效液相凝胶色谱法。方法采用TSK G2000SWXL凝胶色谱柱（TOSOH，7．8mm×300mm），以磷酸盐缓冲液（pH7．0）[0．005m01／L磷酸氢二钠溶液-0．005mol／L磷酸二氢钠溶液（61：39）]-乙腈（95：5）为流动相，检测波长为254nm；流速为0．8mL／min。结果头孢拉定对照品溶液在0．4950～14．8450μg／mL范围内，溶液浓度和峰面积线性关系良好（r=1．0000）。重复性的RSD为2．8％（n=6）。结论本凝胶色谱方法操作简便，专属性强，结果可靠，可用于注射用头孢拉定中有关物质Ⅱ的测定。

Objective To establish an HPLC method for the determination of related substances Ⅱ in cefradine for injection. Methods The analytical column was TSK G2000SWxL （TOSOH, 7.8mm×300mm）; The mobile phase was phosphate buffer （pH7.0）[（0.005mol/L disodium hydrogen phosphate and 0.005mol/L sodium dihydrogen phosphate （61：39）]-acetonitrile （95：5）; The detective wavelength was 254nm, and the flow rate was about 0.8mL/ min. Results Cefradine had good linearity in range of 0.4950-14.8450μg/mL. Repetiton RSD （n=6） was 2.8%. Conclusion The method is simple, specific accurate and reliable, and it is suitable to determine the high molecular weight impurities in cefradine for injection.