头孢他啶及其制剂的有关物质分析及稳定性研究

Study on Related Substances and Stability of Ceftazidime and its Preparation

目的 :头孢他啶遇光、热不稳定 ,易产生降解产物 ,建立 HPLC法测定头孢他啶中间体、降解产物、副产物等有关物质的方法。方法 :色谱柱为 4.6m m× 2 0 0 mm,5 μm,填料为 Spherisorb C1 8,流动相为乙腈 -0 .0 4mol/ L磷酸二氢铵溶液 (1∶ 9) ,氨溶液调 p H至 7.0 ,流速为 1ml/ m in,检测波长为 2 5 4nm。结果 :建立的 HPL C方法 ,测定了头孢他啶及其制剂中的降解产物 7-ACA、副产物Δ -3异构体和其他有关物质。考察了头孢他啶及其制剂的稳定性。结论 :建立的头孢他啶中有关物质的测定方法简单、快速、重现性好 ,优于国外药典报道的方法。

AIM Ceftazidime is unstable to light and heat. In accordance with this report was established a method of HPLC that could determine the related substances. METHODS The analysis conditions were: column, Spherisorb C 18 , 200 mm×4.6 mm, ID 5 μm. Mobile phase: acetonitrile 0.04 mol/L amonia dihydrogen phosphate(1∶9), pH 7.0; 1 ml/min flow rate; UV detection, 254 nm. RESULTS The HPLC method detected ceftazidime and its degradation product (7 ACA), by product (Δ 3 isomer) and related substances. The paper investigated the stability of ceftazidime and its preparation. CONCLUSION The HPLC method described in this report is simple, rapid, accurate and precise, which is better than that of foreign pharmacopeias.