采用高效液相色谱-光电二极管阵列检测法同时测定阿苯达唑及其代谢物的分析方法：一项验证研究
Analytical Method for the Simultaneous Determination of Albendazole and Metabolites Using HPLC-PDA: A Validation Study.
作者信息
Vázquez E Milena, Romero Beatriz, Sahagún Ana M, López Cristina, Puente Raúl de la, Rodríguez José M, Fernández Nélida, Diez M José, Díez Raquel
机构信息
Pharmacology, Department of Biomedical Sciences, Veterinary Faculty, Institute of Biomedicine (IBIOMED), University of Leon, 24071 Leon, Spain.
出版信息
Molecules. 2025 May 3;30(9):2039. doi: 10.3390/molecules30092039.
Albendazole is an anthelmintic drug commonly used in animals and humans against nematodes. A sensitive, accurate, precise, and time-saving high-performance liquid chromatography (HPLC) method for the simultaneous determination of albendazole and metabolites (albendazole sulfoxide and albendazole sulfone) in cattle plasma has been developed and validated. A solid-phase extraction (SPE) was carried out. Separation was performed with an XBridge C18 column (4.6 mm × 250 mm, 5 µm) with gradient elution of acetonitrile:ammonium acetate buffer 0.025 M with pH adjusted to 6.6. The flow rate was 1.2 mL/min, and the PDA detector was set at 292 nm. Calibration curves were linear in the range from 0.025 to 2.0 µg/mL for the three compounds evaluated, with correlation coefficients ≥ 0.99. For the lower limit of quantification (LLOQ), within- and between-run precision and accuracy were satisfactory, with coefficients of variation (CV) ≤ 15.1% and deviations ≤ 117.7%, respectively. The method fulfilled all validation criteria established by the European Medicines Agency guideline (EMA/CHMP/ICH/172948/2019).
阿苯达唑是一种常用于人和动物体内对抗线虫的驱虫药。已开发并验证了一种灵敏、准确、精密且省时的高效液相色谱（HPLC）方法，用于同时测定牛血浆中的阿苯达唑及其代谢物（阿苯达唑亚砜和阿苯达唑砜）。进行了固相萃取（SPE）。采用XBridge C18柱（4.6 mm×250 mm，5 µm），以乙腈：0.025 M乙酸铵缓冲液（pH调至6.6）进行梯度洗脱。流速为1.2 mL/min，PDA检测器设置在292 nm。对于所评估的三种化合物，校准曲线在0.025至2.0 µg/mL范围内呈线性，相关系数≥0.99。对于定量下限（LLOQ），批内和批间精密度及准确度均令人满意，变异系数（CV）分别≤15.1%，偏差≤117.7%。该方法符合欧洲药品管理局指南（EMA/CHMP/ICH/172948/2019）制定的所有验证标准。
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