HPLC法测定注射用氨曲南的有关物质

HPLC determination of the related substances in aztreonam for injection

目的:建立HPLC法测定注射用氨曲南的有关物质检查方法。方法:采用AgilentHC-C18色谱柱(4.6mm×250mm,5μm);流动相:甲醇-磷酸盐缓冲液(取磷酸二氢钾0.8g,加水溶解并稀释至1000mL,用1mol·L-1磷酸溶液调pH至3.0)(20∶80)为流动相,检测波长:254nm;流速:1.0mL·min-1。结果:氨曲南与氨曲南开环物、氨曲南反式异构体及各种杂质能够完全分离。氨曲南开环物在0.04～0.36μg之间呈良好的线性关系(r=0.9999),其平均回收率为99.2%,RSD为0.9%,最低检出限为1.6ng。结论:方法简便、准确,灵敏,可用于注射用氨曲南的有关物质检查。

Objective：An HPLC method for the testing of the related substances in aztreonam for injection was established.Method：The column：Agilent HC-C18column（250 mm×4.6 mm,5 μm）.The mobile phase：methanol-phosphate（dipotassium hydrogen phosphate 0.8 g,dilute to 1000 mL with water,adjust its pH value to 3.0 by1 mol·L-1 phosphoric acid）.The detective wavelength：254 nm.The flow rate：1.0 mL·min-1.Result：E-lsomer and open ring Aztreonam and their related sudstances could be separated completely from aztreonam for injetion.The linear range of open ring Aztreonam was 0.04-0.36 μg（r=0.9999）;the average recovery was 99.2% and RSD 0.9%;the lowest limit of detection was 1.6ng.Conclusion：The method was simple,accurate and sensitive,and can be used for the determination of impurity in aztreonam for injection.