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Validación del método analítico para el control de la calidad y estudio de estabilidad de fenilefrina 10 % colirio

Keywords: hplc/method, phenylephrine, validation.

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Abstract:

phenylephrine is used like mydiatric in eye examinations and other ophthalmic procedures. it is used as vasoconstrictor with local anesthetic agents. in present paper a high ressolution liquid chromatography analytical method was validated to quality control and stability studies of 10 % phenylephrine (eyedrops). mathod was based in separation of active principle through a lichrosorb ro-18 (5 μm) (250 x 4 mm) chromatography column with uv detection at 280 nm using a mobile phase composed by a non-gasified mixture of methanol distilled water (1:1) with 1.1 g of 1-sodium octane-sulphonate by liter adjusted to ph 3,0 with phosphoric acid at a flow speed of 1.0 ml/min. analytical method was linear, accuracy, specific and exact in the interval of study concentrations.

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