Research Article | Volume: 5, Issue: 12, December, 2015

Determination of the Chemical Stability of Various Formulations of Tobramycin Eye-Drops by HPLC Method and Data Analysis by R-GUI Stability Software

María Ana Rosasco Adriana Inés Segall   

Open Access   

Published:  Dec 27, 2015

DOI: 10.7324/JAPS.2015.501202
Abstract

Tobramycin, is a water soluble aminoglycoside antibiotic produced by the fungus Streptomyces tenebrarius and used in a variety of pharmaceutical applications including ophthalmic solutions, suspensions and ointments; inhalation solutions and intravenous administration. There are commercially available eye drops formulations in the Argentinian market that have different conservation conditions. We formulated six eye drops solutions, studied their stability at 2-8°C, 25°C, and 40°C, 75% RH and quantified using USP method. Only half of the formulations studied were found to be stable for two years at ambient temperature which is their expected expiry date and only one for three years in the same condition. One system was unstable in the three conservation conditions studied, including appearance and pH.


Keyword:     Tobramycin eyes-drops stability software generated shelf life formulations.


Citation:

Cátedra de Calidad de Medicamentos, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, CONICET, Junín 956, 1113 Buenos Aires, Argentina.

Copyright:The Author(s). This is an open access article distributed under the Creative Commons Attribution Non-Commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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