Otimização de Metodologia por Cromatografia Líquida em Fase Reversa por Pareamento Iônico para Análise Simultânea de Paracetamol, Cloridrato de Fenilefrina e Maleato de Carbinoxamina em Formulações Farmacêuticas

AUTOR(ES)
DATA DE PUBLICAÇÃO

2008

RESUMO

An alternative methodology by ion-pair reversed phase liquid chromatography for simultaneous analysis of acetaminophen and phenylephrine hydrochloride (association 1) and acetaminophen and carbinoxamine maleate (association 2) in tablets was proposed. Mobile phase consisting of 60% methanol and 40% potassium monobasic phosphate aqueous solution (62.46 mM) added with 0.5 mL trietilamine, 0.25 g sodium lauryl sulfate and 1 mL of phosphoric acid was used, with injection volume of 50 μL, mobile phase flow of 1.0 mL/min, chromatographic column C18 of dimensions 300 x 3.9 mm and particle size of 5 μm maintained at 27C, UV detection at 220 and 300 nm, within 6 min. The proposed method for the analysis of tablets was applied in the analysis of drugs in the pharmaceutical form of oral solution, which contains the three drugs in combination. Due to the presence of interfering in these formulations, the method was again optimized and new mobile phase consisting of 400 mL of acetonitrile, 3520 mL of sodium heptane sulfonate 0.005 M in water, and 4 mL of phosphoric acid was used, with injection volume of 100 μL and flow of 1.0 mL/min. The analytical validation parameters evaluated for association 1 and 2 were: selectivity, linearity, repeatability, intermediate precision, limit of detection, limit of quantification, accuracy and robustness. Due to its simplicity, selectivity, precision, accuracy and rapidity, the methodology can be an interesting alternative for quality assurance in the pharmaceutical industry of these drugs.

ASSUNTO(S)

carbinoxamina ion-pair reversed phase liquid chromatography quimica analitica acetaminophen cromatografia líquida em fase reversa por pareamento iônico paracetamol phenylephrine carbinoxamine formulações farmacêuticas pharmaceutical formulations fenilefrina

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