Abstract

TROCHE CONCEPCION, Yenilen et al. Validation of analytical method to quality control and the stability study of 0.025 % eyedrops Ketotiphen. Rev Cubana Farm [online]. 2010, vol.44, n.3, pp.318-325. ISSN 0034-7515.

The Ketotiphen eyedrop is prescribed to relief the signs and symptoms of allergic conjunctivitis due to its potent H₁ antihistaminic effect showing some ability to inhibit the histamine release and other mediators in cases of mastocytosis. The aim of present paper was to develop and validate an analytical method for the high-performance liquid chromatography, to quality control and the stability studies of 0.025 % eyedrop Ketotiphen. Method was based on active principle separation by means of a Lichrosorb RP-18 (5 µm) (250 x 4 mm), with UV detection to 296 nm using a mobile phase including a non-gasified mixture of methanol:buffer-phosphate (75:25; pH 8.5) adding 1 mL of Isopropanol by each 1 000 mL of the previous mixture at a 1.2 mL/min flow velocity. The analytical method was linear, accurate, specific and exact during the study concentrations.

Keywords : High-performance liquid chromatography; methods; Ketotiphen; validation.

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