Evaluation of the critical points in the validation of 500 mg levofloxacin tablets for dissolution profile
Fecha
2016
Tipo
artículo original
Autores
Ramírez Arguedas, Nils Antonio
González Mora, Esteban
Morera Huertas, Jessica
Carazo Berrocal, Gustavo
Fonseca González, Lidiette
Título de la revista
ISSN de la revista
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Editor
Resumen
The method was validated by ultraviolet spectrophotometry for the
determination of levofloxacin 500 mg tablets using dissolution profiles
to establish therapeutic equivalence. The parameters were satisfactory
according to accuracy and precision in a linear range between 2,0
μg/mL and 8.0μg/mL. Both, the relative error and relative standard
deviation were less than 2%, the recovery was on average of 98,5%,
the quantification limit (QL) obtained was 0,47 μg/mL. The effect of
filters Varian ® Full FlowTM of 70 microns used in the dissolution
equipment autosampler Varian ® 7010 and the effect of light were
evaluated. For the effect of the filter, three concentrations levels were
evaluated (3, 5, 7 μg/mL); no change in the recovery were observed
applying a T-test (both sides, 95% limit of confidence). The effect of
light was explored exposing levofloxacin standard’s to natural and
artificial light for 0, 6, 24, 48, 62 and 86 hours. We find that after 24
hours the response have significance’s changes. With a both-sides, 95 % limit confidence
ANOVA, the homocedasticity (Leven’s test) and normality test (Shapiro-Wilk) were
checked. In conclude the developed method can be used to determine levofloxacine in tablets for profile dissolution, and the filter used does not affect, but light effect is important, and
samples must not be handle for more than 24 hours.
Descripción
Palabras clave
Levofloxacin, Validation, Filter effect, Photosensitivity