Aripiprazole tablets: Development and Validation of a Dissolution Methodology
Journal Title: International Journal of Pharmaceutical Science Invention - Year 2017, Vol 6, Issue 10
Abstract
The aim of this work was to develop and validated a dissolution methodology for aripiprazole tablets by spectrophotometry on ultraviolet light (UV). The dissolution mediums tested were 0.1 M HCl, pH 4.5– citrate buffer and pH 6.8–phosphate buffer, and it was also tested the influence of apparatus and rotation speed. After an UV scan spectrum from 400 to 200 nm to determinate the maximum wavelength absorbance, samples were analyzed by UV visible spectrophotometric method. The selected parameters were 0.1 M HCl as dissolution medium, using paddles as apparatus at rotation speed of 50 rpm, with UV analysis at 249 nm. The method was validated per ICH guidelines, and the results showed that the dissolution methodology for aripiprazole tablets with 0.1 M HCl as dissolution medium, using paddles as apparatus at 50 rpm, with analysis at wavelength of 249 nm, with sampling points at 5, 10, 15, 30, 45 and 60 minutes is specific, linear, precise and accurate and could be applied for quality control of aripiprazole tablets, since there is no official monograph.
Authors and Affiliations
Khaoanny de Souza, Tiago Rafael Sausen
Keywords
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