García PCM, Martínez EV, González CA

Language: Spanish
References: 7
Page:
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ABSTRACT

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.

REFERENCES

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3. The Unites Satated Pharmacopeial, USP 32. 30 ed. Rockville: Mack Printing; 2009. [Versión electrónica].

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7. Dierksneier G. Métodos cromatográficos. La Habana. Ed. Científico-Técnica; 2005. p. 1-4; 256-12