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Validación de un método espectrofotométrico para la determinación de clorhidrato de bromhexina en formas farmacéuticas líquidas, basada en la reacción de Bratton-Marshall.
A spectrophotometric application of the BrattonMarshall reaction is developed for specific determination of bromhexine hydrochloride in presence of methyl and propyl p-hydroxybenzoate in pharmaceutical formulations. The N-naphtylamine was used, instead of N-(1-Naphthyl)ethylendiamine dihydrochloride (Bratton-Marshall reagent), to the fast formation of the colored azo dye which absorbs maximally at 478 nm and was stable at least for 24 h. Analytical performance characteristics were established and statistical analysis of the results has been carried out revealing good precision (method repeatability and intermediate precision) and high accuracy (recovery was > 99.2%). Regression analysis showed good correlation in the concentrations ranges 2.0 - 8.0 mg L -1 (r 2 = 0.998, k = 7, j = 3, n = 21). The procedure was rapid, simple and suitable for quality control application. The validity of the described procedures was assessed and the results are in agreement with those obtained by potentiometric titration for bromhexina bulk drug and by highperformance liquid chromatograph technique for pharmaceutical formulations, at 95% confidence level.
Tópico:
Analytical Methods in Pharmaceuticals
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FuenteRevista de la Facultad de Farmacia de la Universidad de Los Andes