Dissolution test for lamivudine tablets: optimization and statistical analysis.
A comparison of different methods for dissolution test used by five different manufacturer laboratories of lamivudine tablets is made, evaluated, and discussed. Dissolution medium (water and hydrochloric acid pH 1.2), apparatus (paddles and baskets) and time (30 and 60 min) were analyzed. The determination was accomplished by spectrophotometry at 270 nm. Analysis of variance (ANOVA) factorial design 5 x 2 x 2 x 2 with six repetitions, with post hoc multiple comparisons between means conducted by Duncan test at 0.05 significance level was used. After the comparative analysis of the results, optimal dissolution conditions were determined as follows: water as dissolution medium, paddles at the stirring speed of 50 rpm as apparatus and time of 30 min. The method was applied to the dissolution test of samples from eleven batches of tablets, produced by five different laboratories.
Fernandes
Christian
C
Departamento de Produtos Farmacêuticos, Faculdade de Farmácia, Universidade Federal de Minas Gerais, Av. Presidente Antônio Carlos, 6627 Pampulha, CEP 31270-901, Belo Horizonte, MG, Brazil. cfernandes@iqsc.usp.br
Junqueira
Roberto Gonçalves
RG
Campos
Ligia Maria Moreira
LM
Pianetti
Gerson Antônio
GA
D000704:Analysis of Variance; D019380:Anti-HIV Agents / Q000737:chemistry* / Q000592:standards; D006851:Hydrochloric Acid / Q000737:chemistry; D006863:Hydrogen-Ion Concentration; D019259:Lamivudine / Q000737:chemistry* / Q000592:standards; D011786:Quality Control; D012995:Solubility; D013607:Tablets; D014867:Water / Q000737:chemistry
D019380:Anti-HIV Agents; D013607:Tablets; D014867:Water; D019259:Lamivudine; D006851:Hydrochloric Acid