HPLC法测定注射用阿洛西林钠样品中氨苄西林的含量  

Determination of Ampicillin in Azlocillin Sodium for Injection by HPLC

作　　者：顾珉[1] 

机构地区：[1]苏州市药品检验所,江苏苏州215002

出　　处：《中国医药指南》2012年第15期28-30,共3页Guide of China Medicine

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.

关 键 词：注射用阿洛西林钠 氨苄西林 高效液相色谱法 

分 类 号：R914.1[医药卫生—药物化学]