Revista Cubana de Farmacia
versão On-line ISSN 1561-2988
IBANEZ CALVO, Sergio et al. Formula stability of 300 mg Zidovudine tablets. Rev Cubana Farm [online]. 2010, vol.44, n.1, pp. 37-48. ISSN 1561-2988.
Authors developed a validation of analytical method by high-performance liquid chromatography applicable to stability study of Zidovudine (300 mg tablets). The validated analytical method was linear, specific and exact. Above mentione study was develped determing its expiry date. This estudy was conducted by fixed life and of accelerated stability methods by high-performance liquid chromatography, validated in Drugs Research and Development Center (Havana, Cuba). Fixed life study was conducted during 24 months at room temperature whereas the accelerated stability study was conducted exposing the product to light influence and humidity during three months and to temperature during 6 months. Zidovudine formula (300 mg tablets) fulfilled the quality specifications described in Pharmacopeia. After 24 months results of stability study by fixed life showed that product maintained the parameters determining its quality during that period and in accelerated studies there was not a significan degradation of product. Two years was established as expiry date in above mentioned conditions.
Palavras-chave : Zidovudine; validation; stability studies.