HPLC法测定法罗培南钠中的工艺杂质和降解产物
Determination of Process Impurities and Degradation Products in Faropenem Sodium by HPLC
曲喜龙 1王夕婷 1李铁健 1冯中 1张贵民1
作者信息
- 1. 鲁南制药集团股份有限公司,国家手性制药工程技术研究中心,山东临沂 276006;山东新时代药业有限公司,山东临沂 273400
- 折叠
摘要
建立了离子对反相高效液相色谱法测定法罗培南钠(1)中的工艺杂质和降解产物.采用Welch Xtimate C18色谱柱(4.6 mm× 150 mum,3 μm),流动相A为磷酸盐缓冲液(pH 3.0),流动相B为磷酸盐缓冲液和乙腈(体积比50∶50),梯度洗脱.流速为1.0 mL/min,柱温为25 ℃,进样量为20 μL.结果显示,1与各杂质间的分离度良好,且在相应的浓度范围内线性关系良好;各杂质的平均回收率(n=9)为96.35％～104.28％,RSD为1.38％～4.25％.该方法准确度高、灵敏度高、专属性好、重复性好,适用于1中工艺杂质和降解产物的测定.
Abstract
An ion-pair reversed phase high performance liquid chromatography method was established for the determination of the process impurities and degradation products in faropenem sodium(1).The Welch Xtimate C18 column(4.6 mm× 150 mm,3 μm)was used,and the analysis was carried out in the gradient elution mode with phosphate buffer(pH 3.0)as mobile phase A,and phosphate buffer-acetonitrile(50∶50)as mobile phase B.The flow rate was 1.0 mL/min,the column temperature was 25 ℃,and the injection volume was 20 μL.The results showed that the peaks of 1 and its related impurities were separated well,and it was linear for 1 and the related impurities in the corresponding ranges.The average recoveries(n=9)of the impurities were 96.35％-104.28％,with the RSDs of 1.38％-4.25％.The established method has high accuracy,sensitivity,specificity,and repeatability,which is suitable for the determination of process impurities and degradation products in 1.
关键词
法罗培南钠/高效液相色谱法/工艺杂质/降解产物Key words
faropenem sodium/high performance liquid chromatography/process impurity/degradation product引用本文复制引用
出版年
2024
NETL
NSTL
万方数据