Abstract

GARCIA PENA, Caridad Margarita; MARTINEZ ESPINOSA, Vivian  and  GONZALEZ CORTEZON, Ania. Validation of a chromatographic method for quantitation of 50 µg/mL Latanoprost in a Cuban eye drops. Rev Cubana Farm [online]. 2012, vol.46, n.4, pp. 394-401. ISSN 0034-7515.

Introduction: Latanoprost is indicated to treat high intraocular pressure in patients suffering from ocular hypertension or from open angle glaucoma. Objective: to develop and to validate a high performance liquid chromatography-based analytical method for quality control of 50 µg/mL Latanoprost eye drops. Methods: to quantify the active principle of the final product, the separation was performed through Altima C-18 chromatographic column (10 µm) (250 × 4 mm), with ultraviolet detection at 205 nm, and a mobile phase made up of acetonitryle-phosphate buffer of pH= 4.5 (650:350). The quantification of the principle against a reference sample was carried out with the external standard method. Results: the results of the evaluated parameters in the validation of the method were found to be within the set limits. Conclusions: the developed and validated high performance liquid chromatography-based analytical method for the quality control of 50 µg/mL Latanoprost eye drops proved to be specific, linear, exact and precise within the range of the studied concentrations; therefore, it may be safely and reliably used.

Keywords : latanoprost; high performance liquid chromatography; eye drops; quality control.

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