摘要
目的研究HPLC法测定注射用阿洛西林钠样品中氨苄西林的含量。方法采用Kromasil 100A C18柱（200mm×4.6mm,5μm）,流动相为磷酸盐缓冲液（取无水磷酸氢二钾4.09g和磷酸二氢钾0.58g,加水溶解并稀释至1000mL）-乙腈（85∶15）;流速为每分钟1.0mL/min,检测波长210nm,柱温35℃。结果氨苄西林在0.0954~19.0802μg内线性关系良好,氨苄西林平均加样回收率为97.8%,RSD为1.7%。结论本方法简便、可靠、重现性好,可用于注射用阿洛西林钠中氨苄西林的含量测定,为完善注射用阿洛西林钠的质量标准体系提供参考。
Objective To establish a HPLC method for the quantitative determination ampicillin in azlocillin sodium for injection.Methods The HPLC method was performed on a Kromasil 100A C18 column（200mm×4.6mm,5μm） with phosphate buffer solution（anhydrous potassium hydrogen phosphate 4.09g and potassium dihydrogen phosphate 0.58g,using water,dissolved and diluted to 1000mL）-acetonitrile（85∶15） as the mobile phase.The flow rate was 1.0mL/min.The UV detection wavelength was 210nm,and the column temperature was set at 35℃.Results The calibration curves showed good linear response ranged from 0.0954 to 19.0802μg（r2=0.9997） for ampicillin,and the average recoveries were 97.8%（RSD=1.7%）.Conclusion The method is simple,reliable and repeatable,and can be used for the quantitative determination of ampicillin in in azlocillin sodium for injection.
出处
《中国医药指南》
2012年第15期28-30,共3页
Guide of China Medicine
关键词
注射用阿洛西林钠
氨苄西林
高效液相色谱法
Azlocillin sodium for injection
Ampicillin
High performance liquid chromatography
