Determination of Menbutone: Development and Validation of a Sensitive HPLC Assay according to the European Medicines Agency Guideline

Menbutone is often used to stimulate the hepato-digestive activity in case of digestive disorders and hepatic insufficiency different species (cattle, sheep, goats, pigs, horses, dogs) because it has choleretic cholagogue effects increases gastric pancreatic juices. The objective was develop validate an HPLC method quantify menbutone sheep plasma using sparfloxacin as internal standard. mobile phase consisted acetonitrile:monopotassium phosphate solution. validated according EMA guideline (EMEA/CHMP/EWP/192217/2009). Mean retention times were 4.5 2.2 min, respectively. met all specifications guideline, being selective linear range 0.2–100 µg/mL (R2 ? 0.99). within-run precision 0.19–8.21%, with accuracy 102.99–119.52% for lower limit quantitation (LLOQ). For other values (LOW, MED, HIGH) 0.01–4.77%, 85.17–109.67%. LLOQ 0.2 µg/mL, no interference from biological matrix found. Stability at storage conditions also demonstrated. Thus, can be determine concentrations types studies.