UPLC法测定氨苄西林有关物质

目的建立超高效液相色谱检测氨苄西林有关物质的方法。方法采用Acquity UPLC HSS C18色谱柱,以含有冰醋酸、磷酸二氢钾水溶液和乙腈的不同比例的混合液为流动相进行梯度洗脱,流速为0.5 mL·min-1,检测波长为254 nm,柱温为35℃,进样量为5μL。结果氨苄西林在0.272 1³2.652μg·mL-1范围内r≥0.9999;该方法专属性,重复性,耐用性,溶液稳定性良好。各组分间相互无干扰,与HPLC具有同等的检测能力。结论该方法专属性强,灵敏度高,效率较高,可作为氨苄西林有关物质的检测有效方法。

Determination of related substances of ampicillin by UPLC

Objective To develop a UPLC method for the determination of related substances of ampicillin. Methods A gradient method using an Acquity UPLC HSS C18 column and detection at 254 nm was developed,taking mixture of acetic acid and potassium dihydrogen phosphate solution and acetonitrile as mobile phase, at the flow rate of 0. 5 mL . min - 1. Column temperature was 35 ℃ , and injection volume was 5 μL. Results The linear rauges of ampicillin was 0. 272 1 -32. 652 μg . mL -1（ r≥0. 999 9）. This method had fine specificity, repeatability,robustness. And the solution was sta- ble. There was no interference between the components. This method had the same detectability with HPLC meth- od. Conclusion This method had good specificity, sensitivity,and efficiency. It can be used to detect related substances of ampic.illin.