García PCM; Botet GM; Troche CY; Zúñiga DG; Montes de Oca PY

Language: Spanish
References: 4
Page: 205-215
PDF size: 208.99 Kb.

ABSTRACT

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.

REFERENCES

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4. Farmacopea de los Estados Unidos. USP 30. The United States Pharmacopeial Convention. Versión electrónica. New York: Pharm Convention Inc.; 2007.