Spectrofluorimetric and stability-indicating thin layer chromatographic methods for determination of cabergoline, a prolactin inhibitor in pharmaceuticals.

ABSTRACT

Simple, Economic, and selective spectrofluorimetric and stability-indicating thin layer chromatographic (TLC) with fluorescence detection methods were developed for the determination of Cabergoline, a potent prolactin inhibitor, and long-acting dopamine receptor agonist, in bulk drug and pharmaceutical dosage forms based on its native fluorescence. Method A was based on measuring the fluorescence intensity at 338 nm after excitation at 280 nm. The measured fluorescence was directly proportional to the concentration of the drug over the range of 50.0-450.0 ng/mL with a limit of detection of 14.4 and a limit of quantification of 43.7 ng/mL. The TLC method (method B) was employed on TLC silica gel 60 F254 aluminum sheets previously exposed to concentrated (30-34 %) hydrochloric acid vapor. Ethyl acetate n-hexane diethylamine system with a ratio of (10 3 1, v/v/v) developing system was used. The retention factor (Rf) of Cabergoline was 0.58 ± 0.03. Linearity was found to be in the range of 100.0-1500.0 ng/band. The LOD and LOQ were 25.4 and 76.9 ng/band, respectively. The methods were validated successfully according to ICH guidelines.