Abstract
Eflornithine (EFN) is an anti-Trypanosoma brucei agent for the medication of sleeping sickness and widely distributed for the treatment of hirsutism (unwanted facial hair in women). The presented work demonstrates a comprehensive analytical approach for the spectrofluorometric determination of EFN in commercial cream samples and various biological samples. The proposed method is based on the formation of a highly yellow–green fluorescence dihydropyridine derivative after the interaction between EFN and acetylacetone/formaldehyde reagent in a slightly acidic medium. Furthermore, the optimal variables such as reagent volumes, pH of the medium, heating time, buffer volume, heating temperature and diluting solvent were carefully selected to achieve the maximum fluorescence activity. The fluorescence activity for the formed derivative was measured at λemission = 477 nm after λexcitation = 418 nm. Concerning linearity, accuracy, sensitivity, precision and robustness, the presented method was validated and verified according to ICH guidelines. Moreover, the proposed work offered a selective determination for EFN in various brands of pharmaceutical cream without any interference from excipients. Eventually, the current approach was assured to be successful in the estimation of EFN in urine and plasma samples with acceptable recovery results.
Highlights
Eflornithine or α-difluoromethylornithine (EFN) acts as an ornithine decarboxylase
The proposed work offered a selective determination for EFN in various brands of pharmaceutical cream without any interference from excipients
The intravenous doses of EFN were approved by the FDA in 1990 under the trade name of Ornidyl® for the medication of the meningoencephalic stage of human African trypanosomiasis [8]
Summary
Eflornithine or α-difluoromethylornithine (EFN) acts as an ornithine decarboxylase EFN was licensed as a vials pharmaceutical dosage form for the medication of sleeping sickness in Europe, the USA and many countries of Africa [9,10]. The reported spectrophotometric methods are limited to analyse the cited drug in vials dosage only without broaching to cream samples or the biological fluid analysis [17,18,19,20]. A cost-effective and uncomplicated analytical method with sufficient levels of sensitivity and selectivity is required for the quantitation of EFN in biological fluids and pharmaceutical cream. The current work is the first attempt to develop an inexpensive, efficient, well-validated and operated spectrofluorometric method for the sensitive and selective quantification of EFN in its pharmaceutical cream and biological fluids. The method in the presented work is based on the conversion of EFN to a high-fluorescence compound through the condensation interaction between its primary amino group and acetylacetone/formaldehyde as a low-cost fluorogenic reagent
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