2011, Number 2
Stability of a1 mg/mL oral solution zidovudine
García PCM; Morales LI; Martínez EV
Language: Spanish
References: 7
Page: 226-236
PDF size: 117.68 Kb.
ABSTRACT
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.REFERENCES
García Peña CM, León Rodríguez R, Fernández Cervera M, Ibáñez Calvo S, Martínez Espinosa V. Evaluación de desempeño del método de ensayo de disolución para tabletas de zidovudina 300 mg producidas en Cuba. Rev Cubana Farm [Internet]. 2010 Sep [citado 2010 Feb 05]; 44(3): 297-305. Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0034-75152010000300003&lng=es