阿莫西林颗粒中有关物质高效液相色谱分析方法的建立  

Establishment of high performance liquid chromatography method for the determination of related substances in amoxicillin granules

作　　者：郑如程 田胜 程正 江跃 张德兵 ZHENG Rucheng;TIAN Sheng;CHENG Zheng;JIANG Yue;ZHANG Debing(Tongling Institutes for Food and Drug Control,Tongling,Anhui 244061,China;Anhui Anke Hengyi Pharmaceutical Co.,Ltd,Tongling,Anhui 244061,China)

机构地区：[1]铜陵市食品药品检验中心,安徽铜陵244061 [2]安徽安科恒益药业有限公司,安徽铜陵244061

出　　处：《安徽医药》2023年第7期1324-1331,共8页Anhui Medical and Pharmaceutical Journal

基　　金：安徽省药品监督管理局2021年度科技创新项目(AHYJ-KJ-202121)。

摘　　要：目的建立高效液相色谱法测定阿莫西林颗粒中的有关物质。方法2021年6月至2022年2月,采用高效液相色谱法,色谱柱为Agilent Zorbax SB-C8(4.6 mm×250 mm,5μm);流动相A为0.05 mol/L磷酸缓冲液(取0.05 mol/L磷酸二氢钾溶液,用20%氢氧化钠溶液调节pH至5.5),流动相B为0.05 mol/L磷酸缓冲液(取0.05 mol/L磷酸二氢钾溶液,用20%氢氧化钠溶液调节pH至4.5)-乙腈(84∶16);进行梯度洗脱;检测波长为230 nm;流速为2.0 mL/min。结果建立了用于分析阿莫西林颗粒中有关物质的高效液相色谱方法,该方法下主峰与各杂质峰间分离良好,各杂质成分在各自线性范围内与峰面积线性关系良好(r≥0.999),专属性、重复性、精密度、稳定性、耐用性均符合要求。结论该法专属性强、准确度和重复性好,可作为检测阿莫西林颗粒中有关物质的有效方法。Objective To establish a high performance liquid chromatography method for the analysis of related substances in amoxicillin granules.Methods The high performance liquid chromatography method was performed on Agilent Zorbax SB-C8(4.6 mm×250 mm,5μm)column from June 2021 to February 2022;The mobile phase A was 0.05 mol/L phosphate buffer(0.05 mol/L potassium dihydrogen phosphate solution,pH adjusted to 5.5 with 20%sodium hydroxide solution),mobile phase B was 0.05 mol/L phosphate buffer(0.05 mol/L potassium dihydrogen phosphate solution,pH adjusted to 4.5 with 20%sodium hydroxide solution)-acetonitrile(84∶16);gradient elution;the detected wavelength was 220 nm;the flow rate was 2.0 mL/min.Results A high performance liquid chromatography method was established for the analysis of related substances in amoxicillin granules.The impurities and main components were effectively separated,and the impurity components had a good linear relationship with the peak area in their respective linear range(r≥0.999).The specificity,repeatability,precision,stability and durability all met the requirements.Conclusion This method is suitable for determination of the related substances of Amoxicillin granules.

关 键 词：阿莫西林 药物污染 有关物质 高效液相色谱 梯度洗脱 

分 类 号：R927[医药卫生—药学]