摘要
目的建立液相色谱法测定注射用阿莫西林钠舒巴坦钠有关物质。方法梯度洗脱。采用资生堂C_(18)(4.6×250mm,5μm);流动相A:0.04 mol/L磷酸二氢钾溶液(稀磷酸调节p H4.0);流动相B:乙腈;流速:1.0 m L/min;检测波长:230nm;柱温:30℃。结果方法专属性较好,检出限为0.06μg;各杂质与两个主成分峰分离度较好。结论该方法可用于注射用阿莫西林钠舒巴坦钠有关物质的测定。
Objective To develop a HPLC method for the determination of related substances in amoxicillin sodium and sulbactam sodium for injection. Method A shiseido C18 （4.6×250mm, 5μm）was used. The mobile phase A was 0.04 mol/L potassium dihydrogen phosphate（phosphoric acid adjust the pH to 4.0）; mobile phase B was acetonitrile. The flow rate was 1.0 ml/min; the detection wavelength was 230 nm; the column temperature was 30 ℃. Result The method was specific and the limit of detection was 0.06 μg,. The related substances had good separation with two main peaks. Conclusion The method is suitable for the related substances determination of amoxicillin sodium and sulbactam sodium for injection.
出处
《国外医药（抗生素分册）》
CAS
2016年第5期230-233,共4页
World Notes on Antibiotics
