Dissolution test for lamivudine tablets: Optimization and statistical analysis
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.
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Dissolution tests and dissolution profiles are important for establishing pharmaceutical equivalence.
“For that reason, the importance of dissolution tests and dissolution profile for the establishment of pharmaceutical equivalence must be highlighted 3, 4 .”
From Evaluation and comparison of in-vitro dissolution profiles for different brands of amoxicillin capsules (2013) · cites this paper as [3]
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Kassaye, L., & Genete, G. (2013) · African Health Sciences · doi:10.4314/ahs.v13i2.25 · Cited by 80 · see citing works
- Authors
- Fernandes, C., Junqueira, R. G., Campos, L. M. M., & Pianetti, G. A.
- Affiliations
- Universidade Federal de Minas Gerais (BR)
- Corresponding author
- Fernandes, Christian
- Venue
- Journal of Pharmaceutical and Biomedical Analysis
- Publisher
- Elsevier BV
- Published
- 2006-11
- Volume
- 42
- Issue
- 5
- Pages
- 601-606
- ISSN
- 0731-7085 (ISSN-L)
- OpenAlex
- W2045046597
- Cited by
- 20
- References
- 0
- Citations by year
- 2021: 1 · 2020: 1 · 2017: 1 · 2014: 1 · 2013: 4 · 2012: 2
- FWCI
- 1.37
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Pharmaceutical and Biomedical Analysis (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pharmaceutical Quality and Counterfeiting
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
- Keywords
- dissolution testing, dissolution media, paddle apparatus, dissolution time, method optimization, factorial design, spectrophotometric determination, pharmaceutical quality control, interlaboratory comparison
- MeSH terms
- Analysis of Variance, Hydrochloric Acid, Hydrogen-Ion Concentration, Quality Control, Solubility, Tablets, Water, Lamivudine, Anti-HIV Agents
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