Dissolution Test for Mianserin Hydrochloride in Tablets
Autor: | Elfrides Eva Scherman Schapoval, Caren Gobetti, Letícia Lenz Sfair, Martin Steppe |
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Přispěvatelé: | CAPES |
Rok vydání: | 2019 |
Předmět: |
Chromatography
In vitro dissolution Chemistry uv method lcsh:Biotechnology Phosphate buffered saline Hydrochloric acid dissolution test mianserin hydrochloride Coated tablets ivivc lcsh:Chemistry chemistry.chemical_compound lcsh:QD1-999 lcsh:TP248.13-248.65 Drug release Dissolution testing quality control Dissolution Mianserin Hydrochloride |
Zdroj: | Drug Analytical Research, Vol 3, Iss 2, Pp 18-22 (2019) Drug Analytical Research; v. 3, n. 2 (2019); 18-22 |
ISSN: | 2527-2616 |
Popis: | A dissolution test for mianserin hydrochloride in coated tablets containing 30 mg was developed and validated using a fast ultraviolet spectrophotometric method. The appropriate conditions were determinate after testing sink conditions, agitation spped and dissolution medium. The sink conditions tested showed that mianserin hydrochloride was soluble in 0.01 and 0.1 M hydrochloric acid (HCl), acetate buffer pH 4.1 and 5.0 and phosphate buffer pH 6.8. Then, dissolution tests were performed to investigate the drug release in each medium. Optimal conditions to carry out the dissolution test were 900 mL 0.1 M HCl and USP apparatus 2 (paddle) at 50 rpm stirring speed. The quantification method was also adapted and validated. The UV method showed specificity, linearity, precision and accuracy. The in vitro dissolution test can be used to evaluate the drug release profile and the data was used as an aid to establish a possible correlation with in vivo data. |
Databáze: | OpenAIRE |
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