高效液相色谱法测定替戈拉生中有关物质的研究
Determination of related substances in tegoprazan by HPLC
张磊 1苑艳飞 2林小晖 3王丽华 1徐树娟 1申应德1
作者信息
- 1. 临沂市检验检测中心,山东 临沂 276001
- 2. 泰安市食品药品检验检测研究院,山东 泰安 271000
- 3. 济南市食品药品检验检测中心,济南 250000
- 折叠
摘要
目的 建立高效液相色谱法测定替戈拉生原料药中3种有关物质的含量.方法 采用Agilent Proshell 120 EC-C18 色谱柱(4.6 mm× 100 mm,2.7 μm);流动相 A 为 0.01 mol·L-1 醋酸铵缓冲液,流动相B为乙腈,线性梯度洗脱;检测波长为220 nm;流速为0.7 mL·min-1;柱温为40 ℃;进样量为10μL.结果 杂质A～C的线性范围分别为0.0972～1.944 μg·mL-1(r=0.9999)、0.0509～1.018 μg·mL-1(r=0.9997)及0.1089～2.178 μg·mL-1(r=0.9997),平均回收率分别为96.27％、95.40％和96.10％,RSD分别为2.1％、2.3％和2.2％.结论 该方法准确可靠,灵敏度高,可用于替戈拉生原料药有关物质的控制.
Abstract
Objective To determine the 3 related substances in tegoprazan by HPLC.Methods An Agilent Proshell 120 EC-C18(4.6 mm×100 mm,2.7 μm)column was used.The mobile phase A was 0.01 mol·L-1 ammonium acetate buffer,and the mobile phase B was acetonitrile,with linear gradient elution.The detection wavelength was 220 nm.The flow rate was 0.7 mL·min-1,and the column temperature was 40 ℃.The injection volume was 10 μL.Results The calibration curves of impurity A,B and C were 0.0972～1.944 μg·mL-1(r=0.9999),0.0509～1.018 μg·mL-1(r=0.9997),and 0.1089～2.178 μg·mL-1(r=0.9997).The average recovery was 96.27％,95.40％and 96.10％,with RSDs of 2.1％,2.3％and 2.2％.Conclusion The method is accurate and reliable,which can be used for the quality control of tegoprazan.
关键词
替戈拉生/有关物质/高效液相色谱法/含量测定Key words
tegoprazan/related substance/HPLC/content determination引用本文复制引用
出版年
2024
NETL
NSTL
万方数据