HPLC法测定头孢他啶和精氨酸的含量

Determination of Ceftazidime and Arginine by HPLC

目的建立同时测定注射用头孢他啶（含精氨酸）中头孢他啶和精氨酸的含量的质量控制方法。方法采用C18柱，0．01mol／L戊烷磺酸钠（用冰醋酸调节pH值至3．4，40％氢氧化钾溶液调节pH值至4．0）：甲醇（85：15）为流动相，检测波长206／lm。结果头孢他啶在100．47～301．41μg／ml范围内，精氨酸在40．11～100．28μg/ml范围内线性关系良好，r值分别为0．9999与1，平均回收率分别为100．0％，99．3％，相对标准偏差值（RSD）分别为0．6％与0．5％。结论该法操作简单，结果准确，可用于以精氨酸为助溶剂的注射用头孢他啶的质量控制。

Objective To establish a quality control method for the simultaneous determination of ceftazidime and arginine in ceftazidime for injection. Methods The C18 column was used, with a mobile phase of 0.01 mol/L sodium pentanesulfonate and methanol （85：15 ）, and the detection wavelength was 206 nm. Results The linear ranges of ceftazidime and arginine were 100.47 -301.41μg/ml and d0.11 -100.28μg/ml, respectively. The average recoveries were 100.0% for ceftazidime, and 99.3% for arginine. RSD were 0.6% for ceftazidime, and 0.5% for arginine. Conclusion The method is convenient, accurate, and can be used for the quality control of ceftazidime for injection.