高效分子排阻法测定注射用氨曲南中聚合物的含量

Determination of the Polymers in Aztreonam for Injection by HPSEC

目的:建立对氨曲南中高分子聚合物分析方法。方法:采用高效分子排阻法(HPSEC)对氨曲南中高分子聚合物的含量进行测定和方法学验证;色谱柱:Sepax SRT SEC-100(7.8mm×300mm,5μm),流动相:p H7.0的磷酸盐缓冲液-乙腈(95∶5)检测波长:254nm,流速约0.5m L/min,进样:20μL,自身对照外标法定量。结果:采用该方法测定3批注射用氨曲南中的聚合物,均小于0.2%。结论:该方法能够较好地分离氨曲南中聚合物,可用于注射用氨曲南中聚合物的检验。

Objective：To establish a Analysis method for the determination of the polymers in aztreonam. Methods：The analysis was earried out using HPSEC method for determination of the polymer in aztreonam and the analysis method was validated. Conditions： Column： Sepax SRT SEC-100（7.8mm×300mm,5μm）,The composition of mobile phase was phosphate buffer （pH7.0）and acetonitrile （95：5）. Detection wavelength was 254nm and the flow rate was 0.SmL/min. The injection volumn for test was 20μL and the result was calculated by external standard method. Results：Using this method, the polymer in aztreonam for injection of 3 Batches were all lower than 0.2%. Conclusions：The polymers can be completely separated from aztreonam. The method was reliable and applicable for the determination of the polymers of aztreonam.