离子色谱法测定盐酸头孢吡肟/L-精氨酸中N-甲基吡咯烷

Determination of N-methylpyrrolidine in Cefepime Hydrochloride/L-Arginine by Ion Chromatography

目的建立离子色谱法测定盐酸头孢吡肟／L-精氨酸中N-甲基吡咯烷残留量。方法色谱柱为Metrosep C2-100阳离子交换柱（10cm×4mm×7μm），流动相为3mmol／LHNO，溶液-乙腈（30：70），流速为1．0ml／min，电导检测器。结果N-甲基吡咯烷在1．00-30．04μg／ml时线性关系良好，相关系数r=0．99995：检测限为0．19μg／ml；平均加样回收率为94．O％，RSD为1．8％。结论本法简便、准确、灵敏度高。

Objective To establish a ion chromatography method for the determination of residual N- methylpyrrolidine in cefepime hydrochloride/L-Arginine. Methods The determination was performed on a Metrosep C2-100 column （10 cm×4 min×7μm）. The mobile phase was a mixture of 3 mmol/L HNO3-acetonitrile （30 ： 70）. The flow rate was 1.0 ml/min. A conductivity detector was used. Results The standard curve was linear over the range of 1.00-30.04 μg/ml （r=0.99995）. The detection limit for N-methylpyrrolidine was 0.19 μg/ml. The average recovery was 94.0% （RSD=1.8%, n = 9）. Conclusion The method is simple, accurate, and suitable for the determination of residual N-methylpyrrolidine in Cefepine hydrochloride/L-Arginine.