Evaluation of the critical points in the validation of 500 mg levofloxacin tablets for dissolution profile

Abstract

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.