用二维高效液相色谱法测定人血浆中洛拉替尼的浓度
Determination of lorlatinib concentration in human plasma by two-dimensional high performance liquid chromatography
李威 1翟婧 1龙明辉 1潘勇 1廖德华1
作者信息
- 1. 湖南省肿瘤医院、中南大学湘雅医学院附属肿瘤医院药学部,湖南长沙 410003
- 折叠
摘要
目的 建立二维高效液相色谱法测定人血浆中洛拉替尼的浓度,为其治疗药物监测提供分析方法.方法 在二维高效液相色谱法中,一维色谱柱:SX1E-1A(50 mm ×3.5 mm,5 μm),流速:0.8 mL·min-1;二维色谱柱:SCB-C18(125 mm ×4.6 mm,5 µm),流速:1.0 mL·min-1.柱温:40 ℃;紫外检测波长:317 nm,进样量:500 μL.考察该方法的专属性、标准曲线与最低定量限、精密度与回收率、稳定性.结果 人血浆中洛拉替尼在11.72～1 018.98 ng· mL-1呈现良好线性关系,回归方程为y=944.50x-588.90(R2=0.999 7),最低定量限为11.72 ng·mL-1,低、中、高3个质控样品的提取回收率在97.61％～99.86％,日内和日间精密度均小于5.29％,证明该方法检测性能良好.结论 该方法具有稳定性能好、灵敏度高、抗干扰能力强等特点,适用于人血浆中洛拉替尼的浓度测定.
Abstract
Objective To establish a method for the determination of lorlatinib in human plasma by two-dimensional high performance liquid chromatography.Methods In the two-dimensional high performance liquid chromatography method,one-dimensional column SX1E-1A(50 mm × 3.5 mm,5 μm)and two-dimensional column SCB-C18(125 mm × 4.6 mm,5 μm)were used with flow rates of 0.8 mL·min-1 and 1.0 mL·min-1,respectively.The column temperature was 40 ℃,The UV detection wavelength was 317 nm,and the sample size was 500 μL.This study investigated the specificity,standard curve and minimum quantification limit,precision and recovery rate,as well as stability of the method.Results The concentration of lolatinib in human plasma showed a good linear relationship in the range of 11.72-1 018.98 ng·mL-1,and the regression equation was y=944.50x-588.90(R2=0.999 7).The minimum limit of quantification was 11.72 ng·mL-1.The extraction recovery rates of the three quality control samples were 97.61％-99.86％,and the intra-day and inter-day precisions were less than 5.29％,indicating that the detection performance of the method was good.Conclusion The method has the characteristics of good stability,high sensitivity and strong anti-interference ability,and is suitable for the determination of loratinib in human plasma.
关键词
洛拉替尼/二维高效液相色谱/治疗药物监测Key words
lorlatinib/two-dimensional high performance liquid chromatography/therapeutic drug monitoring引用本文复制引用
基金项目
湖南省自然科学基金(2023JJ60462)
出版年
2024
国家科技期刊平台
NSTL
万方数据