| 摘要: |
| 目的:建立高效液相色谱(HPLC)法检测儿童吡仑帕奈的血药浓度。方法:采用SHIMSEN ANkyLo C18(4. 6 mm×250 mm,
5 μm)色谱柱,流动相0. 05%磷酸-乙腈(52 ∶ 48),柱温30 ℃,流速1 mL/ min,进样量40 μL,检测波长290 nm,检测癫痫患儿的
吡仑帕奈血药浓度。结果:血清中的杂质对吡仑帕奈的检测无干扰。吡仑帕奈在80~2 500 μg/ L 线性关系良好(r = 0. 999 8),
定量限80 μg/ L;实测浓度在标示浓度±10%,日内/ 日间精密度良好(RSD 均<6. 0%),回收率95. 73%~103. 88%(RSD<2. 3%);
样品室温放置24 h、4 ℃放置7 d、-20 ℃放置14 d 和反复冻融3 次稳定性良好(RSD<3. 0%)。结论:该方法检测结果准确,具
有较高的灵敏度和稳定性,能满足临床对患儿吡仑帕奈血药浓度的监测及药动学研究要求。 |
| 关键词: 癫痫 吡仑帕奈 高效液相色谱 血药浓度 |
| DOI：doi:10.13407/j.cnki. jpp.1672-108X.2024.11.002 |
|
| 基金项目:基金项目:安徽医科大学科研基金,编号2020xkj241。 |
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| Determination of Perampanel Concentration in Children by High Performance Liquid Chromatography |
| Li Wanxia, Zhang Yin, Cheng Run, Wang Yan |
| (Anqing Municipal Hospital, Anqing Medical Center, Anhui Medical University,
Anhui Anqing 246000, China) |
| Abstract: |
| Objective: To establish the high performance liquid chromatography (HPLC) method for the determination of pirampanel
concentration in children. Methods: SHIMSEN ANkyLo C18 (4. 6 mm×250 mm, 5 μm) column was adopted to separate the serum
samples by a mobile phase of 0.05% phosphoric acid-acetonitrile (52 ∶ 48), the column temperature was 30 ℃, the flow rate was 1 ml/ min,
the sample volume was 40 μL, and the detection wavelength was 290 nm. The concentration of perampanel in children with epilepsy was
detected. Results: The impurities in serum did not interfere with the detection of perampanel. The linear range of perampanel was from
80 to 2,500 μg/ L (r = 0. 999,8), and the quantitative limit was 80 μg/ L. The accuracy was ±10% of the marked value, and the
intra-day and inter-day precision was good (RSD<6. 0%), with recovery rate of 95. 73% to 103. 88% (RSD<2. 3%). The samples
stored at room temperature for 24 h, at 4 ℃ for 7 d, at -20 ℃ for 14 d and repeatedly frozen and thawed for 3 times had good stability
(RSD< 3. 0%). Conclusion: The method is accurate, sensitive and stable, which can meet the clinical requirements of blood
concentration and pharmacokinetic study of pirampanel in children. |
| Key words: epilepsy perampanel high performance liquid chromatography blood concentration |
