HPLC法同时测定注射用头孢他啶中组分含量

Simultaneous Determination of Components of Ceftazidime for Injection by HPLC

建立同时测定注射用头孢他啶中头孢他啶和精氨酸的含量检测方法。采用HPLC法,以迪马C18柱（150 mm×4.6 mm,5.0μm）为色谱柱,乙腈-0.015 mol/L辛烷磺酸钠的0.1 mol/L磷酸二氢钠溶液（用氢氧化钠试液调节p H值至5.0）（8∶92）为流动相,流速为1.0 m L/min,检测波长为206 nm。结果表明,被测定的头孢他啶在45~675μg/m L（r=0.999 9）,精氨酸在15~225μg/m L（r=0.999 9）范围内线性关系良好;平均加样回收率为99.02%~100.70%（RSD≤2.0%）。该方法简便、可靠、准确,可同时对头孢他啶和精氨酸的含量进行质量控制。

Simultaneous determination method of content ceftazidime and arginine in ceftazidime for injection was establised.The method of HPLC was used with Dima C18column（150 mm × 4.6 mm, 5 m） as chromatographic column,acetonitrile-0.1 mol/L solution of sodium hydrogen phosphate and 0.015 mol/L octane sulfonic acid sodium salt（p H adjusted to 5 with sodium hydroxide solution）（8∶92） as mobile phase, flow rate of 1 m L/min and the detection wavelength of 206 nm. Results show that by the determination of ceftazidime in 45~675 μg/m L（r=0.999 9）, arginine in 15~225μg/m L（r=0.999 9）,the linear relationship is good; the average recovery rate is 99.02%~100.70%（RSD≤2.0%）. The method is simple, reliable, accurate, and can also control the content of ceftazidime and arginine.