J. Pharm. Pharmacogn. Res., vol. 10, no. 5, pp. 888-895, September-October 2022.
DOI: https://doi.org/10.56499/jppres22.1423_10.5.888
Original Article
Validación de la cromatografía líquida de alto rendimiento acoplada a espectrometría de masas para determinar albendazol sulfóxido en plasma humano
[Validation of high performance liquid chromatography coupled to mass spectrometry to determine albendazole sulfoxide in human plasma]
Jaime Rosales-Rimache1*, Saúl Santiváñez2, Luis Moreno-Exebio3, Miguel Grande3, María Flores-Rodríguez3, María Eguiluz2, Hugo García4,5
1Facultad de Salud Pública y Administración. Universidad Peruana Cayetano Heredia, Lima, Perú.
2Facultad de Medicina, Universidad Nacional de Centro del Perú, Huancayo, Perú.
3Instituto Nacional de Salud, Centro Nacional de Control de Calidad, Lima, Perú.
4Centro de Salud Global, Universidad Peruana Cayetano Heredia, Lima, Perú.
5Unidad de Cisticercosis, Instituto Nacional de Ciencias Neurológicas, Perú.
*E-mail: jaime.rosales@upch.pe, jaime.rosales.rimache@gmail.com
Abstract
Context: Albendazole is used in the treatment of cysticercosis and hydatid disease, and its prolonged administration can generate adverse effects attributed to the active metabolite, albendazole sulfoxide (ABZSO), whose measurement requires validated methods that help monitor patients under treatment.
Aims: To validate a high-performance liquid chromatography method with mass detection (HPLC-MS) for the determination of ABZSO in human plasma.
Methods: HPLC-MS was performed on C18 columns (100 × 4.6 mm × 3.5 µm) and mobile phase composed of methanol, water and ammonia solution (25%) (800:200:0.1 v /v/v) at a flow rate of 0.5 mL/minute. The calibration curve was built with an albendazole standard, and detection in a triple quadrupole system.
Results: The method was linear (1-1500 ng/mL, R2 = 0.999) with a detection limit of 1 ng/mL. ABZSO concentrations at 1, 5, 50, 100, 200, 500, 1000, and 1500 ng/mL had relative standard deviations of 10.4, 8.4, 7.8, 2.9, 7.4, 3.2, 3.4 and 1.3%. It was highly precise with a mean coefficient of variation of 1.411%, and accurate with a bias of -14.7; 2.8 and -0.8% in ABZSO concentrations of 5, 500 and 1000 ng/mL. The average recovery was 89.2%, and the stability of ABZSO after refrigeration had an average coefficient of variation of 2.3%.
Conclusions: The HPLC-MS method is valid and reliable to determine ABZSO, and could be used in pharmacokinetic, bioequivalence, and other studies that evaluate the biological monitoring of patients receiving oral treatment with albendazole.
Keywords: albendazole; analytical validity; HPLC.
Resumen
Contexto: El albendazol es utilizado en el tratamiento de cisticercosis e hidatidosis, y su administración prolongada puede generar efectos adversos atribuidos al metabolito activo, albendazol sulfóxido (ABZSO), cuya medición requiere métodos validados que ayuden al monitoreo en pacientes en tratamiento.
Objetivos: Validar un método de cromatografía líquida de alto rendimiento con detección de masas (HPLC-MS) para la determinación de ABZSO en plasma humano.
Métodos: La HPLC-MS fue realizada en columnas C18 (100 × 4,6 mm × 3,5 µm) y fase móvil compuesta de metanol, agua y solución de amonio (25%) (800:200:0,1 v/v/v) a un flujo de 0,5 mL/minuto. La curva de calibración fue construida con un estándar de albendazol y la detección en un sistema de triple cuadrupolo.
Resultados: El método fue lineal (1-1500 ng/mL, R2 = 0,999) con límite de detección de 1 ng/mL. Las concentraciones de ABZSO a 1, 5, 50, 100, 200, 500, 1000 y 1500 ng/mL tuvieron desviaciones estándar relativas de 10,4; 8,4; 7,8; 2,9; 7,4; 3,2; 3,4 y 1,3%. Fue altamente preciso con coeficiente de variación promedio de 1,411%, y exacto con sesgo de -14,7; 2,8 y -0,8% en concentraciones de ABZSO de 5, 500 y 1000 ng/mL. La recuperación promedio fue de 89,2%, y la estabilidad del ABZSO tras la refrigeración tuvo un coeficiente de variación promedio de 2,3%.
Conclusiones: El método HPLC-MS es válido y confiable para determinar ABZSO, y podría ser empleado en estudios de farmacocinética, bioequivalencia, y otros que evalúen el monitoreo biológico de pacientes que reciben tratamiento oral con albendazol.
Palabras Clave: albendazol; HPLC; validez analítica.
Citation Format: Rosales-Rimache J, Santivañez S, Moreno-Exebio L, Grande M, Flores-Rodríguez M, Eguiluz M, Garcia H (2022) Validación de la cromatografía líquida de alto rendimiento acoplada a espectrometría de masas para determinar albendazol sulfóxido en plasma humano. [Validation of high performance liquid chromatography coupled to mass spectrometry to determine albendazole sulfoxide in human plasma]. J Pharm Pharmacogn Res 10(5): 888–895. https://doi.org/10.56499/jppres22.1423_10.5.888
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