RT info:eu-repo/semantics/article
T1 Determination of Menbutone: Development and Validation of a Sensitive HPLC Assay according to the European Medicines Agency Guideline
A1 López Cadenas, Cristina
A1 Díez Láiz, Raquel
A1 Rodríguez Lago, José Manuel
A1 Sierra Vega, Matilde
A1 García Viéitez, Juan José
A1 Fernández Martínez, María Nélida
A1 Diez Liébana, María José
A1 Sahagún Prieto, Ana María
A2 Farmacologia
K1 Farmacología
K1 Veterinaria
K1 HPLC
K1 EMA guideline
K1 menbutone
K1 validation
K1 32 Ciencias Médicas
K1 3209 Farmacología
AB [EN] Menbutone is often used to stimulate the hepato-digestive activity in case of digestive disorders and hepatic insufficiency in different species (cattle, sheep, goats, pigs, horses, dogs) because it has choleretic and cholagogue effects and increases gastric and pancreatic juices. The objective was to develop and validate an HPLC method to quantify menbutone in sheep plasma using sparfloxacin as internal standard. The HPLC mobile phase consisted of acetonitrile:monopotassium phosphate solution. The method was validated according to EMA guideline (EMEA/CHMP/EWP/192217/2009). Mean retention times of menbutone and sparfloxacin were 4.5 and 2.2 min, respectively. The method met all specifications of the EMA guideline, being selective and linear in the range of 0.2–100 g/mL (R2 0.99). The within-run precision range was 0.19–8.21%, with an accuracy of 102.99–119.52% for the lower limit of quantitation (LLOQ). For the other values (LOW, MED, HIGH) the precision range was 0.01–4.77%, with an accuracy of 85.17–109.67%. The LLOQ was 0.2 g/mL, and no interference from the biological matrix was found. Stability of menbutone in the biological matrix at different storage conditions was also demonstrated. Thus, the method can be used to determine menbutone concentrations in plasma sheep in different types of studies
PB MDPI
LK https://hdl.handle.net/10612/17960
UL https://hdl.handle.net/10612/17960
NO López, C., Díez, R., Rodríguez, J. M., Sierra, M., García, J. J., Fernández, N., Diez, M. J., & Sahagún, A. M. (2022). Determination of Menbutone: Development and Validation of a Sensitive HPLC Assay according to the European Medicines Agency Guideline. Separations, 9(4). https://doi.org/10.3390/SEPARATIONS9040084
DS BULERIA. Repositorio Institucional de la Universidad de León
RD 15-jun-2024