Resumen

BENITEZ HECHAVARRIA, Ernesto; VARGAS COPLAND, Emilia Carolina; COLINDRES GALINDO, German Eduardo  y  ENAMORADO COLINDRES, Klelia Felissia. Naphazoline hydrochloride assay by high performance liquid chromatography in an ophthalmic solution. Rev Cubana Farm [online]. 2014, vol.48, n.3, pp. 359-370. ISSN 1561-2988.

Introduction: the United States Pharmacopeia specifies how to titer naphazoline hydrochloride in an ophthalmic solution, but suggests the use of a column with nitrile groups attached to porous silica which is barely used. Objective: to develop and to validate an alternative method by high resolution liquid chromatography for the quantification of naphazoline hydrochloride in an ophthalmic solution. Methods: the developed method was isocratic separation with a Zorbax SB-C18 column (4.6 x 150 mm, 5 µm) and ultraviolet detection set at 225 nm. The mobile phase was buffer and acetonitrile (85:15 ratio, v/v) and the buffer was KH2PO4 (22 mM) and triethylamine (30 mM), adjusted to pH 3 with concentrated phosphoric acid. The validation method was performed pursuant to the Guide Q2(R1) of the International Conference on Harmonization and the following parameters were evaluated: specificity, precision, accuracy, linearity and range. The method uncertainty was also estimated. Results: regarding the specificity, the placebo did not show any signal in the naphazoline hydrochloride zone; the relative standard deviation indexes for intermediate precision were less than 1.5 %; as to accuracy, the recovery was 101.52 % and the linearity showed absence of curvature in the 50 to 150 % range. The estimated expanded uncertainty reached 3 % of the stated amount. Conclusions: all the validation parameters under evaluation were within the set allowable limits, thus this method is suitable for the intended purposes.

Palabras clave : naphazoline hydrochloride; High Performance Liquid Chromatography; HPLC; validation; uncertainty.

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