Abstract

GARCIA PENA, Caridad Margarita; MORALES LACARRERE, Iván  and  MARTINEZ ESPINOSA, Vivian. Stability of a1 mg/mL oral solution zidovudine. Rev Cubana Farm [online]. 2011, vol.45, n.2, pp.226-236. ISSN 0034-7515.

The carrying out of a high-performance liquid chromatography analytical method was assessed; applicable to stability study of oral solution zidovudine (1 mg/mL) was made. The analytical method was linear, precise, specific and exact in the study concentrations. The stability study of oral solution zidovudine (1 mg/mL) was conducted determining expiring date. The shelf life study was conducted over 24 months at room temperature; whereas that of accelerated stability was conducted with the product under wet and temperature conditions; analysis was carried out over three months. Formula met quality specifications described in Pharmacopeia. Results from the shelf life study demonstrated that product keeps the parameters determining its quality during that time and in accelerated studies there was not significant product degradation. Under above mentioned conditions two years were established as expiring date.

Keywords : Zidovudine; validation; stability studies.

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