HPLC测定注射用复方头孢西丁钠

Determination of Compound Cefoxitin Sodiumfor Injection by HPLC

建立注射用复方头孢西丁钠中两种有效成分的定量分析方法。采用Kromasil C18色谱柱(250mm×4.6mm,5μm),以乙腈-磷酸二氢钾(0.03mol.L-1)-10%四丁基氢氧化铵(35∶63.5∶1.5,V/V/V),用85%的磷酸调pH=4为流动相,流速1.0mL.min-1,进样量10μL,柱温30℃,在230nm的波长下进行他唑巴坦、头孢西丁两种物质的定量分析。他唑巴坦、头孢西丁浓度分别在0.125—0.50mg.mL-1(r=0.9998)、0.5—2.0mg.mL-1(r=0.9999)范围内与峰面积呈良好线性关系;方法的回收率(n=9)分别为99.7%、100.2%;样品相对标准偏差分别为1.5%、0.2%;稳定性实验表明上述两种成分在室温条件下8h内稳定。本法首次建立了注射用复方头孢西丁钠的含量测定方法,该法快速、简便、准确,重复性好,适用于该药物的含量测定。

A quantitative analytical method was developed to determine the two active principle in compound cefoxitin sodium and tazobactam sodium in cefoxitin sodium/tazobactam sodium for injection.The two components were quantitatively analyzed on Kromasil C18 column（250mm×4.6mm,5μm） with mobile phase of methanol-potassium dihydrogen phosphate solution（0.03mol·L^-1-10% tetrabutyl ammonium hydroxide（35∶63.5∶1.5,V/V/V）,adjusting pH to 4 by 85% phosphoric acid,The flow rate was 1.0mL·min^-1,the detection wavelength was 230nm,the injection volume was10 μL and column temperature was 30℃.The linearity of tazobactam sodium was 0.125—0.50mg·mL^-1（r=0.9998）,the recovery was 99.7%,RSD was 1.5% but the linearity of cefoxitin sodium was 0.5—2.0mg·mL^-1（r=0.9999）,the recovery was 100.2%,RSD was 0.2%.The stability test showed that the two components were stable at room temperature for 8h.This method is fast,simple and accurate with good repeatability,that suits for the determination of cefoxitin sodium and tazobactam sodium in cefoxitin sodium/tazobactam sodium for injection.