Validation of analytical methods for analysis and stability studies of anti-retrovirais in pharmaceutical preparations. / Validação de métodos para análise e estudos de estabilidade de anti-retrovirais em preparações farmacêuticas
AUTOR(ES)
Andréia Montoro Taborianski
DATA DE PUBLICAÇÃO
2003
RESUMO
The acquired immunodeficiency syndrome is characterized by causing physical and functional depletion of the organisms immune system, through the cytophatic infection of CD4+ cells. Several antiretroviral drugs has been developed and commercially made available. In order to assure the quality control of drugs it is necessary to develop and validate new analytical methodologies to perform the quantitative determination of drugs and stability studies of pharmaceutical formulations by determining the drug itself and its degradation products. In this research two analytical techniques, direct UV/VIS spectrophotometry and high performance liquid chromatography (HPLC), were used for the quantitative determination of zidovudine (AZT) and stavudine (d4T) in pharmaceutical preparations. Both methods were validated and parameters like linearity, precision, accuracy, specificity, limit of detection and limit of quantification, were determined. The validated HPLC method was also applied for quantitative determination of timine, a degradation product of AZT and d4T. The validated HPLC method was applied to accelerate stability studies of AZT and d4T in different pharmaceutical preparations. The stability studies were performed at three different conditions: room temperature, 40 oC / 75% RH and 50 oC / 90% RH. Both AZT and d4T (Industry A) and d4T (Industry B) pharmaceutical preparations presented a zero order degradation reaction. The three formulations presented a shelf-life of 10, 3 and 2 months, respectively, at 50 oC / 90% RH.
ASSUNTO(S)
accelerated stability studies validação de métodos analíticos stavudine zidovudine estudos de estabilidade acelerada estavudina zidovudina validation of analytical methods
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