| 引用本文: | 王君燕,王慧娟,张慧芬,何铠锋,缪静.HPLC测定人血浆中吡仑帕奈的浓度及其儿科临床应用[J].中国现代应用药学,2022,39(12):1580-1584. |
| WANG Junyan,WANG Huijuan,ZHANG Huifen,HE Kaifeng,MIAO Jing.Determination of Perampanel Concentration in Human Plasma by HPLC and Its Clinical Application in Pediatrics[J].Chin J Mod Appl Pharm(中国现代应用药学),2022,39(12):1580-1584. |
|
| 摘要: |
| 目的 建立HPLC测定人血浆中吡仑帕奈浓度的方法并考察其临床应用。方法 采用Agilent ZORBAX SB-C18(4.6 mm×150 mm，5 μm)色谱柱，流动相为0.05%磷酸(pH 3.5)-乙腈(56∶44)，流速为1 mL·min–1，柱温为30℃，检测波长为290 nm。测定癫痫患儿的吡仑帕奈浓度并考察影响血药浓度的风险因素。结果 吡仑帕奈在75~2 500 μg·L–1内线性良好，定量限为75 μg·L–1，准确度不超过标示值的±10%，精密度的变异系数均≤5%，回收率为97.6%~101.0%，在实验涉及的各种条件下稳定性良好。利用该方法测定了51例癫痫患儿的吡仑帕奈血浆谷浓度，所得浓度结果为91.6~1 681.9 μg·L–1；年龄影响吡仑帕奈浓度，<5岁患者的吡仑帕奈谷浓度显著低于5~12岁患者，但与≥12岁患者无显著差异。结论 该方法操作简便，具有较高的准确性和灵敏度，能满足吡仑帕奈治疗药物监测的分析要求，年龄对吡仑帕奈的谷浓度存在显著影响。 |
| 关键词: 吡仑帕奈 高效液相色谱法 血药浓度 临床应用 |
| DOI：10.13748/j.cnki.issn1007-7693.2022.12.011 |
| 分类号:R917.101 |
| 基金项目:浙江省药学会医院药学专项科研资助项目(2021ZYY04,2021ZYY15);浙江省新一轮卫生商层次人才培养工程(2021年度医培新秀) |
|
| Determination of Perampanel Concentration in Human Plasma by HPLC and Its Clinical Application in Pediatrics |
|
WANG Junyan, WANG Huijuan, ZHANG Huifen, HE Kaifeng, MIAO Jing
|
|
Department of Pharmacy, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou 310052, China
|
| Abstract: |
| OBJECTIVE To establish an HPLC method for the determination of perampanel concentration in human plasma.METHODS The plasma samples were separated on an Agilent ZORBAX SB-C18(4.6 mm×150 mm, 5 μm) column using a mobile phase of 0.05% orthophosphoric acid(pH 3.5)-acetonitrile(56:44) at a flow rate of 1 mL·min-1. The column temperature was 30℃, and detection wavelength was 290 nm. Perampanel concentration in children with epilepsy and investigation of risk factors affecting blood concentration was determined. RESULTS The linear range of perampanel was 75-2 500 μg·L-1, and the limit of quantitation was 75 μg·L-1. The accuracy didn't exceed ±10% of the marked value, the precision was less than 5%, and the recovery was 97.6%-101.0%. The samples were stable at the different conditions detected. A total 51 plasma samples of children diagnosed with epilepsy were measured by the established method, and the trough concentrations of perampanel were 91.6-1 681.9 μg·L-1. Age influenced the perampanel concentrations, the concentrations of patients younger than 5 years old was significantly lower than that aged 5-12 years, but no significant difference was found when compared with that aged older than 12 years and younger than 5 years. CONCLUSION The method is simple, accurate, sensitive and can be used for the therapeutic drug monitoring of perampanel in clinic. The age of patients has a significant impact on the trough concentrations of perampanel. |
| Key words: perampanel HPLC plasma concentration clinical application |
