Spectrofluorimetric analysis of menbutone in veterinary formulations: Application to residue determination in bovine meat and milk

Abstract

A simple, rapid, and sensitive spectroflourimetric method was developed for the determination of menbutone. The method is based on measuring the native fluorescence of the alkaline aqueous methanolic solution of the cited drug at its optimum excitation and emission wavelengths at λem 378 nm, upon excitation at λex 300 nm. The method showed good linearity over the range of 0.2-2.0 µg/mL with a detection and quantitation limits of 7.25 and 24.15 ng/mL, respectively. The suggested method was successfully applied to the analysis of menbutone in its commercial veterinary formulations and the results obtained were in good agreement with those given with the manufacturer method. The method was further extended to the determination of menbutone residues in bovine meat and milk, and the results were satisfactory. The recoveries obtained were in the 98.50-102.25% range. No organic solvents were used in the extraction procedures, therefore, the proposed method can be considered as a type of 'green' chemical process. KEYWORDS

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

“…MB is used in the European Union (EU) to stimulate the hepato-digestive activity in the case of digestive disorders and hepatic insufficiency by increasing pancreatic juices, bile and peptic secretion between 2 to 5 times the normal levels, maintaining this effect for 2-3 h after administration [2][3][4]. In the last decade, several veterinary medicines containing this active ingredient have been approved for use in most EU countries (by national authorization or mutual-recognition procedures) [5,6].…”

“…As far as we know, up to date, few methodologies have been reported to determine MB. These methods include spectrophotometry [4], HPLC-UV detection [3,9,10], HPLC-MS [3,11] and Micellar Liquid Chromatography (MLC) [12], and none of them have been carried out in sheep nor validated in accordance with the European Medicines Agency (EMA) guideline on bioanalytical method validation [13]. Moreover, these methods show a low sensitivity, are tedious and sometimes require specific instruments not always available.…”