Analytical Method for the Simultaneous Determination of Albendazole and Metabolites Using HPLC-PDA: A Validation Study.

IF 4.2 2区化学 Q2 BIOCHEMISTRY & MOLECULAR BIOLOGY

Molecules Pub Date : 2025-05-03 DOI:10.3390/molecules30092039

E Milena Vázquez, Beatriz Romero, Ana M Sahagún, Cristina López, Raúl de la Puente, José M Rodríguez, Nélida Fernández, M José Diez, Raquel Díez

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Abstract

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).

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HPLC-PDA同时测定阿苯达唑及其代谢物的分析方法：验证性研究。

阿苯达唑是一种通常用于动物和人类对抗线虫的驱虫药。建立了同时测定牛血浆中阿苯达唑及其代谢物（阿苯达唑亚砜和阿苯达唑砜）的高效液相色谱（HPLC）方法，该方法灵敏、准确、精确、省时。采用固相萃取法（SPE）。采用XBridge®C18色谱柱（4.6 mm × 250 mm, 5µm）进行分离，乙腈：醋酸铵缓冲液0.025 m， pH调节至6.6梯度洗脱。流速为1.2 mL/min， PDA检测器波长为292 nm。3种化合物在0.025 ~ 2.0µg/mL范围内均呈线性，相关系数≥0.99。定量下限（LLOQ）内、间精密度和准确度均较好，变异系数(CV)≤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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来源期刊

Molecules 化学-有机化学

CiteScore

7.40

自引率

8.70%

发文量

7524

审稿时长

1.4 months

期刊介绍： Molecules (ISSN 1420-3049, CODEN: MOLEFW) is an open access journal of synthetic organic chemistry and natural product chemistry. All articles are peer-reviewed and published continously upon acceptance. Molecules is published by MDPI, Basel, Switzerland. Our aim is to encourage chemists to publish as much as possible their experimental detail, particularly synthetic procedures and characterization information. There is no restriction on the length of the experimental section. In addition, availability of compound samples is published and considered as important information. Authors are encouraged to register or deposit their chemical samples through the non-profit international organization Molecular Diversity Preservation International (MDPI). Molecules has been launched in 1996 to preserve and exploit molecular diversity of both, chemical information and chemical substances.