Quantificação de antibióticos beta-lactâmicos em medicamentos veterinários: determinação de amoxicilina e ampicilina por cromatografia líquida de alta eficiência

Abstract

Recebido em 8/11/12; aceito em 30/4/13; publicado na web em 10/6/13 QUANTIFICATION OF BETA-LACTAM ANTIBIOTICS IN VETERINARY DRUGS: AMOXICILLIN AND AMPICILLIN DETERMINATION BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY. This work focused on the development and validation of an RP-HPLC-UV method for quantification of beta-lactam antibiotics in three pharmaceutical samples. Active principles analyzed were amoxicillin and ampicillin, in 3 veterinary drugs. Mobile phase comprised 5 mmol L-1 phosphoric acid solution at pH 2.00, acetonitrile with gradient elution mode and detection wavelength at 220 nm. The method was validated according to the Brazilian National Health Surveillance regulation, where linear range and linearity, selectivity, precision, accuracy and ruggedness were evaluated. Inter day precision and accuracy for pharmaceutical samples 1, 2 and 3 were: 1.43 and 1.43%; 4.71 and 3.74%; 2.72 and 1.72%, respectively, while regression coefficients for analytical curves exceeded 0.99. The method had acceptable merit figure values, indicating reliable quantification. Analyzed samples had active principle concentrations varying from-12 to +21% compared to manufacturer label claims, rendering the medicine unsafe for administration to animals.

Quality evaluation of solid pharmaceutical preparations for veterinary use containing cephalexin

“…The precariousness of the quality of medicines can determine the spread of diseases among animals, risks of illness as a result of the lack of adequate content, stability of the formulation, presence of impurities from degradation products or traces of synthesis route reagents (10). In a study carried out in Sub-Saharan Africa, a market highly affected by counterfeit veterinary drugs, the research identified cases of adverse reactions and therapeutic ineffectiveness.…”

“…A study that performs the quantification of beta-lactam antibiotics in veterinary drugs shows that the three drugs evaluated showed concentration of the drug different from that indicated in the package insert, ranging from -12% to +21% (10). The present study was conducted using CEP as the antimicrobial of choice due to its high application in veterinary medicine, especially in pets, and due to the variety of preparations available in the national market.…”

“…Few bibliographic references report lack of conformity of veterinary products, added to the fact that many of these deviations are not notified (12). The use of medications must guarantee that the patient receives the concentration of the active ingredient correctly for the purpose for which it was intended: whether for therapeutic, prophylactic, or diagnostic purposes (10). The lack regarding the evaluation of the conformity of these drugs, as well as the expressive increase in veterinary prescriptions leads to the search for information about the qualification of pharmaceutical preparations available in the national market.…”

Caracterização molecular e fenotípica de >i<Klebsiella>/i< spp. produtoras de NDM

“…Os betalactâmicos consistem em uma classe de antimicrobianos que incluem derivados de penicilinas, e diferem de acordo com a estrutura química dos radicais ligados ao anel betalactâmico, essencial para sua ação antimicrobiana. Podem ser divididos em classes como penicilinas, associações de β-lactâmicos e inibidores de betalactamases, cefens, monobactâmicos e penens (MIGUEL, 2013).…”