HPLC法测定注射用头孢替唑钠的含量及其有关物质

Determination of Ceftezole Sodium for Injection and Its Related Substances by HPLC

目的:建立HPLC法测定注射用头孢替唑钠含量及其有关物质。方法:色谱柱为Xterra ODS C_(18)(250 mm×4.6 mm, 5μm);以乙腈-水(以枸橼酸调节水的pH为2.40±0.01)(15:85)为流动相,流速1.0 ml·min^(-1);检测波长为254 nm。结果:头孢替唑线性范围为0.1～1.2 mg·ml^(-1),r=0.999 9,平均回收率为101.1%,RSD0.4%(n=9)。结论:方法简便、准确、专属性强,辅料不干扰主药测定,可用于注射用头孢替唑钠的质量控制。

Objective： To develop a RP-HPLC method for the detertmination of ceflezole sodium for injection and its related shb-stances. Method： The Xterra C18 column（250 mm ×4.6 mm, 5 μm） used, the mobil phase consisted of acetonitrile-water（ adjusted pH to 2.40 ±0.01 with citric acid） （ 15： 85）, the flow rate was 1.0 ml.min ^-1 and the UV detection was 254nm. Result： The calibration curves of ceftezole was linear within the range of 0.1 - 1.2 mg. ml ^- 1 （r = 0. 999 9）. The average recovery was 100.1% with RSD of 0.4% （ n = 9）. Conclusion ： This method is simple and rapid, it can be used for quality control of ceftezole sodium for injection and its related substances.