Analytical Method for the Simultaneous Determination of Albendazole and Metabolites Using HPLC-PDA: A Validation Study
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 sul...
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2025-05-01
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| author | E. Milena Vázquez Beatriz Romero Ana M. Sahagún Cristina López Raúl de la Puente José M. Rodríguez Nélida Fernández M. José Diez Raquel Díez |
| author_facet | E. Milena Vázquez Beatriz Romero Ana M. Sahagún Cristina López Raúl de la Puente José M. Rodríguez Nélida Fernández M. José Diez Raquel Díez |
| author_sort | E. Milena Vázquez |
| collection | DOAJ |
| description | 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<sup>®</sup> 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). |
| format | Article |
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| institution | OA Journals |
| issn | 1420-3049 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | MDPI AG |
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| spelling | doaj-art-8cd1cc9871b7456caec966244d0c3ceb2025-08-20T01:49:14ZengMDPI AGMolecules1420-30492025-05-01309203910.3390/molecules30092039Analytical Method for the Simultaneous Determination of Albendazole and Metabolites Using HPLC-PDA: A Validation StudyE. Milena Vázquez0Beatriz Romero1Ana M. Sahagún2Cristina López3Raúl de la Puente4José M. Rodríguez5Nélida Fernández6M. José Diez7Raquel Díez8Pharmacology, Department of Biomedical Sciences, Veterinary Faculty, Institute of Biomedicine (IBIOMED), University of Leon, 24071 Leon, SpainPharmacology, Department of Biomedical Sciences, Veterinary Faculty, Institute of Biomedicine (IBIOMED), University of Leon, 24071 Leon, SpainPharmacology, Department of Biomedical Sciences, Veterinary Faculty, Institute of Biomedicine (IBIOMED), University of Leon, 24071 Leon, SpainPharmacology, Department of Biomedical Sciences, Veterinary Faculty, Institute of Biomedicine (IBIOMED), University of Leon, 24071 Leon, SpainPharmacology, Department of Biomedical Sciences, Veterinary Faculty, Institute of Biomedicine (IBIOMED), University of Leon, 24071 Leon, SpainPharmacology, Department of Biomedical Sciences, Veterinary Faculty, Institute of Biomedicine (IBIOMED), University of Leon, 24071 Leon, SpainPharmacology, Department of Biomedical Sciences, Veterinary Faculty, Institute of Biomedicine (IBIOMED), University of Leon, 24071 Leon, SpainPharmacology, Department of Biomedical Sciences, Veterinary Faculty, Institute of Biomedicine (IBIOMED), University of Leon, 24071 Leon, SpainPharmacology, Department of Biomedical Sciences, Veterinary Faculty, Institute of Biomedicine (IBIOMED), University of Leon, 24071 Leon, SpainAlbendazole 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<sup>®</sup> 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).https://www.mdpi.com/1420-3049/30/9/2039albendazolealbendazole sulfoxidealbendazole sulfoneEMA guidelineHPLCvalidation |
| spellingShingle | E. Milena Vázquez Beatriz Romero Ana M. Sahagún Cristina López Raúl de la Puente José M. Rodríguez Nélida Fernández M. José Diez Raquel Díez Analytical Method for the Simultaneous Determination of Albendazole and Metabolites Using HPLC-PDA: A Validation Study Molecules albendazole albendazole sulfoxide albendazole sulfone EMA guideline HPLC validation |
| title | Analytical Method for the Simultaneous Determination of Albendazole and Metabolites Using HPLC-PDA: A Validation Study |
| title_full | Analytical Method for the Simultaneous Determination of Albendazole and Metabolites Using HPLC-PDA: A Validation Study |
| title_fullStr | Analytical Method for the Simultaneous Determination of Albendazole and Metabolites Using HPLC-PDA: A Validation Study |
| title_full_unstemmed | Analytical Method for the Simultaneous Determination of Albendazole and Metabolites Using HPLC-PDA: A Validation Study |
| title_short | Analytical Method for the Simultaneous Determination of Albendazole and Metabolites Using HPLC-PDA: A Validation Study |
| title_sort | analytical method for the simultaneous determination of albendazole and metabolites using hplc pda a validation study |
| topic | albendazole albendazole sulfoxide albendazole sulfone EMA guideline HPLC validation |
| url | https://www.mdpi.com/1420-3049/30/9/2039 |
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