中国临床药学杂志2025，Vol.34Issue(6)：454-458,5.DOI:10.19577/j.1007-4406.2025.06.009
UPLC测定拉考沙胺血药浓度的建立及其在癫痫患儿中的应用
Establishment of the UPLC for lacosamide quantification in serum and its application in pediatric patients with epilepsy
摘要
Abstract
AIM To establish an ultra-high performance liquid chromatography(UPLC)for lacosamide quantification in human serum and to apply the approach for therapeutic drug monitoring(TDM)in pediatric patients with epilepsy.METHODS After the plasma samples were pretreated with 7％perchloric acid solution,20 μL of the supernatant was directly analyzed by the UPLC.The separation was carried out on an ACQUITY UPLC BEH C18(50 mm×2.1 mm,1.7μm)column,with 0.1％formic acid-acetonitrile(85∶15)as the mobile phase,at a flow rate of 0.2 mL·min-1,and a column temperature of 40℃,with a detection wavelength of 265 nm.The method specificity,standard curve,recovery,precision and stability were investigated.A total of 158 pediatric patients with epilepsy who underwent TDM of lacosamide using the UPLC were collected and analyzed for monitoring results.RESULTS The serum concentration of lacosamide was linear within 0.5-50.0 μg·mL-1(r2＞0.999 6),and the limit of detection was 0.5 μg·mL-1.The recovery rates for extraction varied between 96.9％and 103.7％.The relative standard deviation(RSD)of intra-day precision was under 7.63％,while the inter-day precision was below 8.22％.Additionally,the RSD of stability test showed results of less than 14.85％.Results of the TDM indicated that the trough concentrations of lacosamide in the serum ranged from 1.3 μg·mL-1 to 25.6 μg·mL-1.Among the pediatric patients studied,49 patients(31.01％)had concentrations lower than 2.0 μg·mL-1,90 patients(56.96％)had concentrations between 2.0 μg·mL-1 and 10.0 μg·mL-1,and 19 patients(12.03％)had concentrations greater than 10.0μg·mL-1.CONCLUSION The UPLC developed in the study for lacosamide quantification in serum has the advantages of simplicity,rapidity and sensitivity,and could be used for TDM of lacosamide in pediatric patients with epilepsy.关键词
拉考沙胺/超高效液相色谱法/治疗药物监测/癫痫/儿童Key words
lacosamide/ultra-high performance liquid chromatography/therapeutic drug monitoring/epilepsy/child分类
医药卫生引用本文复制引用
李惠英,黎林波,李发双,张力麟..UPLC测定拉考沙胺血药浓度的建立及其在癫痫患儿中的应用[J].中国临床药学杂志,2025,34(6):454-458,5.基金项目
云南省科技厅科技计划项目(编号202301AY070001-280) （编号202301AY070001-280）
云南省卫生科技成果转化项目(编号YX-2023-02) （编号YX-2023-02）
