反相高效液相色谱法测定注射用头孢米诺钠含量及其有关物质

Determination of Content and Related Substances of Cefminox Sodium by RP-HPLC

目的采用反相高效液相色谱法测定注射用头孢米诺钠含量及其有关物质。方法色谱柱为ZorbaxODSC18柱(250mm×4.6mm,5μm),流动相为水(980mL水和10mL冰醋酸混合)-甲醇(990∶10),检测波长为254nm,流速为1mL/min,柱温为30℃。结果头孢米诺钠线性范围是0.25～3.0mg/mL(r=0.9998),最低检出限为0.1μg/mL,最低定量限为0.4μg/mL,平均回收率为100.02%,RSD为0.83%。结论该方法简便、快速,结果准确、可靠,适用于头孢米诺钠含量及其有关物质的测定。

Objective To determine the content and the related substances of cefminox sodium by RP- HPLC. Methods The separation was performed on a Zorbax ODS-C18 column（250 mm×4.6 mm, 5μm）, the mobile phase was composed of water （complex 10 mL acetic acid with 980 mL water ）-methanol（990 ： 10）, the flow rate was 1.0 mL/min with detection wavelength of 254 nm and column temperature of 30℃. Results The linear range of the determination by RP - HPLC was 0.25-3 mg/mL, the correlation coefficient was 0.999 8, the least detective range was 0. 1μg/mL, the least quantitative range was 0.4μg/mL. The average recovery rate was 100. 02% , with RSD of 0. 83%. Conclusion The method is simple, rapid and the results is accurate and suitable for the determination of the content and the related substances of cefminox sodium.