Dissolution test for lamivudine tablets: optimization and statistical analysis

J Pharm Biomed Anal. 2006 Nov 16;42(5):601-6. doi: 10.1016/j.jpba.2006.05.009. Epub 2006 Jun 22.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Analysis of Variance
  • Anti-HIV Agents / chemistry*
  • Anti-HIV Agents / standards
  • Hydrochloric Acid / chemistry
  • Hydrogen-Ion Concentration
  • Lamivudine / chemistry*
  • Lamivudine / standards
  • Quality Control
  • Solubility
  • Tablets
  • Water / chemistry

Substances

  • Anti-HIV Agents
  • Tablets
  • Water
  • Lamivudine
  • Hydrochloric Acid