离子交换色谱法测定注射用盐酸头孢吡肟含量

Determination Content of Cefepine by Ion Exchange Chromatography for Injection

目的用离子交换色谱法（ICE）测定头孢吡肟含量。方法采用PartisilSCX10μm柱（250mm×4．6mm）。以5×10^-4mol／L（NH4）2SO4水溶液-乙腈（90：10）为流动相，于258mm波长处检测，流速为1．0ml／min，柱温40℃。结果盐酸头孢吡肟在8．520～4．260μ／ml浓度范围内，峰面积与浓度呈良好线性关系（r=0．99997）。平均回收率为100．7％，相对标准偏差值（RSD）为0．43％。结论该方法准确、专属、快速，可用于测定盐酸头孢吡肟的含量，及有关物质检查。

Objective To determine the content of the cefepine by ion exchange chromatography. Methods The analysis was performed on a Partisil SCX 10 μm column （250 mm ×4.6 mm）. The mobile phase consisted of 5 × 10^-4 moL/L ammonium sulfate solution-acetonitrile （90： 10） with a flow rate of 1.0 ml/min, and the column temperature was 40℃, the UV detection wave length was 258 nm. Results The calibration curve of peak area and concentration of cefepime hydrochloride was linear （r =0. 99997）. The average recovery was 100.7% , with RSD 0.43%. Conclusion The method is accurate, rapid for the content determination of cefepime hydrochloride and related substance.