| 摘要: |
| [摘要]目的：建立测定癫痫患儿拉考沙胺（LCM）血药浓度的超高效液相色谱（UPLC）方法。方法：内标为盐酸普萘洛尔；色谱柱为Waters ACQUITY UPLC BEH C18柱（100 mm×2.1 mm，1.7 µm）；流动相为甲醇-10 mmol/L磷酸二氢铵溶液（45:55，用甲酸调至pH 4.0），流速0.2 mL/min，进样量2 μL；检测波长240 nm；柱温30 ℃。结果：LCM和普萘洛尔的保留时间分别为2.468 min和5.475 min。LCM（X）在1.0~40.0 μg/mL浓度范围内与峰面积（Y）的线性关系良好（Y=0.049 4X+0.022 2，r=0.999 8），检测下限为0.50 μg/mL（S/N=4），定量下限为1.00 μg/mL（S/N=12）。日内精密度1.88%~3.29%，日间精密度2.33%~5.68%，准确度88.75%~105.29%，加样回收率为96.58%~101.76%。LCM血清样品的室温稳定性、长期稳定性和冻融稳定性均较好（偏差<15%）。结论：该方法预前处理简单，分析灵敏度高、特异性强，稳定可靠，能够满足临床LCM治疗药物浓度监测的需求。 |
| 关键词: 超高效液相色谱法 拉考沙胺 血药浓度 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2022.10.002 |
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| 基金项目:新疆维吾尔自治区人民医院科研基金资助项目,编号20190315。 |
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| Determination of Blood Concentration of Lacosamide in Children with Epilepsy by Ultra-High Performance Liquid Chromatography |
| Zhao Ting1, Sun Yan2, Fen Jie1, Wang Tingting1, Sun Li1, Li Hongjian1, Yu Luhai1 |
| (1. People’s Hospital of Xinjing Uygur Autonomous Region, Urumqi 830000, China; 2. Children’s Hospital of Xinjing Uygur Autonomous Region, Urumqi 830000, China) |
| Abstract: |
| [Abstract] Objective: To establish the ultra-high performance liquid chromatography (UPLC) method for determination of blood concentration of lacosamide (LCM) in children with epilepsy. Methods: Phenytoin sodium was used as the internal standard. The Waters ACQUITY UPLC BEH C18 column (100 mm×2.1 mm, 1.7 µm) was used, the mobile phase was methanol-10 mmol/L ammonium dihydrogen phosphate solution (45∶55, adjusted with formic acid to pH 4.0), the flow rate was 0.2 mL/min, the injection volume was 2 μL, the detection wavelength was 240 nm, and the column temperature was 30 ℃. Results: The retention time of LCM and propranolol was 2.468 min and 5.475 min, respectively. LCM (X) showed good linearity with peak area (Y) in the concentration range from 1.0 to 40.0 μg/mL (Y=0.049,4X+0.022,2, r=0.999,8), the lower limit of detection was 0.50 μg/mL (S/N=4) and the lower limit of quantification was 1.00 μg/mL (S/N=12). The intra-day precision was from 1.88% to 3.29%, the inter-day precision was from 2.33% to 5.68%, the accuracy was from 88.75% to 105.29%, and the extraction recovery rate was from 96.58% to 101.76%. The room temperature stability, long-term stability and freeze-thaw stability of LCM samples were good (deviation <15%). Conclusion: The UPLC method has the advantages of simple pre-treatment, high analytical sensitivity, specificity, stability and reliability, and can meet the needs of clinical drug concentration monitoring for LCM treatment. |
| Key words: ultra-high performance liquid chromatography lacosamide blood concentration |
