注射用头孢曲松钠含量测定探究与方法学验证

Investigation and Method Verification of Sodium Ceftreasone for Injection

文章建立了注射用头孢曲松钠的含量测定方法。采用Agilent Ecilpse plus C18(4.6 mm×250 mm,5μm)色谱柱;0.02 mol/L正辛胺-乙腈(73∶27)为流动相;柱温30℃;检测波长254 nm。研究结果表明HPLC法能准确测定头孢曲松的含量,线性范围为10~200μg/mL,R=0.9999;平均回收率为109.3%,RSD(%)=0.92%;重复性RSD(%)=0.11%;精密度RSD(%)=0.05;系统适应性头孢曲松钠与头孢曲松反式异构体峰值分离度大于6.0。此方法简单、灵敏可靠、专属性强、准确度高,可用于注射头孢曲松钠的质量控制。

This paper established a method for the determination of ceftriaxone sodium for injection.Agilent Ecilpse plus C18(4.6 mm×250 mm,5μm)column was used,0.02 mol/L n-octylamine acetonitrile(73:27)as mobile phase.The column temperature was 30℃.The detection wavelength was 254 nm.The results show that HPLC method can accurately determine the content of ceftriaxone,with linear range of 10-200μg/mL,R=0.9999.The average recovery was 109.3%,RSD(%)=0.92%,Repeatability RSD(%)=0.11%,Precision RSD(%)=0.05.The peak separation degree of ceftriaxone sodium and ceftriaxone trans isomer is greater than 6.0.The method is simple,sensitive,reliable,specific and accurate,and can be used for the quality control of ceftriaxone sodium injection.