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Revista Cubana de Farmacia
Print version ISSN 0034-7515On-line version ISSN 1561-2988
Abstract
BOTET GARCIA, Martha; GARCIA PENA, Caridad Margarita; MARTINEZ ESPINOSA, Vivian and MORENO CORREOSO, Bárbara. Stability of 2 % Pilocarpine eyedrops. Rev Cubana Farm [online]. 2009, vol.43, n.4, pp.61-67. ISSN 0034-7515.
Authors carried out the study of 2 % Pilocarpine eyedrops stability and its expiry date was determined. Shelf life and accelerated stability methods were used by high-performance liquid chromatography, validated in Drugs Development and Research Center. Shelf life study was carried out during 24 months at room temperature, whereas in the accelerated stability study the product undergoes the temperature influence during 6 months. The 2 % Pilocarpine formula fulfilled with quality specifications described in Pharmacopeia. Results of stability by shelf life after 24 months suggest that product maintain the parameter determining its quality during that period and in accelerated studies there was not a significant degradation of product. The expiry date was of 2 years under the fixed conditions.
Keywords : Pilocarpine accelerated study; shelf life; high-performance liquid chromatography.