Abstract

GARCIA PENA, Caridad Margarita et al. Development and validation of an analytical method for quality control and the stability of the eyedrops 10 % Phenylephrine and the 1 % Tropicamide. Rev Cubana Farm [online]. 2011, vol.45, n.2, pp.205-215. ISSN 0034-7515.

An analytical high-performance liquid chromatography method was developed and validated applicable to quality control and to stability study of 10 % phenylephrine plus eyedrops 1 % tropicamide. To quantify simultaneously both active principles in the finished product, separation was carried out through a Lichrosorb RP-18 (15 µm) (260 x 4 mm) column chromatography, with ultraviolet detection at 253 nm using the mobile phase composed of methanol: distilled water (1:1), with 1.1 g of sodium 1-octasulfanate by litre and pH fitted to 3.0 with phosphoric acid and the quantification of this front to a reference sample using the external standard method. The analytical method developed was linear, precise, specific and accurate in the rank of study concentrations, established for the quality control and stability study of the finished product since there were not analytical methods designed for these aims.

Keywords : Phenylephrine; tropicamide; validation.

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