HPLC法测定阿莫西林钠克拉维酸钾有关物质  

Determination of Related Substances in Amoxicillin Sodium and Clavulanate Potassium for Injection by HPLC

作　　者：王凤秋 邹春阳 孟祥军[2] 

机构地区：[1]辽宁卫生职业技术学院,辽宁沈阳110101 [2]沈阳医学院药物中心,辽宁沈阳110034

出　　处：《辽宁化工》2012年第5期537-538,540,共3页Liaoning Chemical Industry

摘　　要：建立阿莫西林钠克拉维酸钾有关物质的测定方法。色谱柱采用十八烷基硅烷键合相硅胶为填充剂,流动相A为0.01 mol/L磷酸二氢钾溶液(用2 mol/L氢氧化钠溶液调节pH值至6.0);流动相B为0.01 mol/L磷酸二氢钾溶液(用2 mol/L氢氧化钠溶液调节pH值至6.0)-乙腈(20︰80),检测波长230 nm,流速1.0 mL/min。定量限为0.8 ng,最低检测限为0.24 ng,各种破坏性样品的分离度符合规定。阿莫西林钠克拉维酸钾相关物质分离度均大于1.5,符合要求。本方法迅速,准确,灵敏度高,专属性强,可用于本品有关物质的测定。A method for determination of related substances in amoxicillin sodium and clavulanate potassium was established.Kromasil C18 column was used,mobile phase A was 0.01 mol/L potassium dihydrogen phosphate(adjusting pH to 6.0 with 2 mol/L sodium hydroxide),mobile phase B was 0.01 mol/L potassium dihydrogen phosphate(adjusting pH to 6.0 with 2 mol/L sodium hydroxide)-acetontrile(20︰80),detection wavelength was 230 nm.The flow rate was 1.0 mL/min.The limit of quantitation was 0.8 ng,the minimum detection limit was 0.24 ng.The separation degrees of various destructive effect samples were greater than 1.5,it was up to the specification.The method is rapid,accurate,high sensitivity and strong specificity,can meet the need for determination of related substances in amoxicillin sodium and clavulanate potassium.

关 键 词：HPLC法 阿莫西林钠克拉维酸钾 有关物质 

分 类 号：O657[理学—分析化学]