注射用头孢地嗪钠有关物质测定方法的建立

Establishment of a method for the determination of cefodizime sodium for injection

目的建立高效液相色谱法测定注射用头孢地嗪钠的有关物质。方法采用梯度洗脱法,色谱柱为菲罗门,Luna.C18(2)柱(100A;4.6×250mm,5μm),以磷酸盐缓冲液(取磷酸二氢钾0.87g与无水磷酸氢二钠0.22g,加水溶解并稀释至1000ml)为流动相A;以乙腈为流动相B。检测波长215nm;流速1.0ml/min。结果经过对色谱条件优化,头孢地嗪与相邻杂质峰以及各杂质峰之间的分离度均大于1.5。结论该方法满足头孢地嗪峰与已知杂质峰及未知杂质峰之间分离度的要求,更适合注射用头孢地嗪钠有关物质的测定。

Objective To establish a HPLC method for the determination of cefodiazine sodium for injection. Methods Gradient elution method was used. The chromatographic column was Luna■C18 (2) column( 100A;4.6 × 250mm, 5μm). Phosphate buffer was used as mobile phase A( 0.87 g potassium dihydrogen phosphate and 0.22 g anhydrous disodium hydrogen phosphate dissolved and diluted to 1000ml), while acetonitrile was used as mobile phase B. The detection wavelength was 215 nm and the flow rate was 1.0 ml / min. Results The related substances of cefodizime sodium for injection were determined by HPLC gradient elution method. The chromatographic conditions in the literature were optimized and the separation degree between cefodizime and adjacent impurity peaks and impurity peaks was more than 1.5. Conclusion This method meets the requirements of separation between cefodizime peak and known impurity peak and is more suitable for the determination of related substances of cefodizime sodium for injection.