HPLC法测定阿莫西林钠克拉维酸钾中的22个杂质

Determination of Twenty-two Related Substances in Amoxicillin Sodium and Potassium Clavulanate Mixtures by HPLC

目的建立HPLC法同时测定阿莫西林钠克拉维酸钾原料中22个已知杂质含量的方法。方法采用YMC Triart C_(18)色谱柱(4.6×250 mm,3μm);流动相A为0.05 mol·L^(-1)磷酸二氢钾溶液(pH=5.9)-乙腈(99∶1),流动相B为0.05 mol·L^(-1)磷酸二氢钾溶液(pH=5.9)-乙腈(80∶20),梯度洗脱;流速为1.0 mL·min^(-1),检测波长为215 nm,柱温为25℃。结果该方法下主峰与各杂质间分离良好,各成分在各自线性范围内与峰面积线性关系良好(r>0.999);对各杂质的校正因子进行了计算,定量限、检出限及回收率等均符合规定。结论该法专属性强、灵敏度高、准确度和重复性好,可用于检测阿莫西林钠克拉维酸钾的有关物质。

OBJECTIVE To establish an HPLC method for determining the contents of twenty-two related substances in Amoxicillin Sodium and Potassium Clavulanate mixtures.METHODS YMC Triart C_(18) column(4.6×250 mm,3μm)was used.The mobile phase A was 0.05 mol·L^(-1)potassium dihydrogen phosphate(pH 5.9)-acetonitrile(99∶1),and the mobile phase B was 0.05 mol·L^(-1)potassium dihydrogen phosphate(pH 5.9)-acetonitrile(80∶20),by gradient elution.The flow rate was 1.0 mL·min^(-1),the detective wavelength was 215 nm,and the column temperature was 25℃.RESULTS The impurities and main components were effectively separated with good linearity(r>0.999),satisfactory detection limits,limits of quantification,and recovery.The correction factors of all impurities were calculated,respectively.CONCLUSION The method is specific,accurate,sensitive,reliable,and suitable for the determination of related substances in amoxicillin sodium and potassium clavulanate mixtures.