Open AccessDissolution Test for Mianserin Hydrochloride in Tablets
Author(s) -
Letícia Lenz Sfair,
Caren Gobetti,
Martin Steppe,
Elfrides Eva Scherman Schapoval
Publication year - 2019
Publication title -
drug analytical research
Language(s) - English
Resource type - Journals
ISSN - 2527-2616
DOI - 10.22456/2527-2616.97029
Subject(s) - dissolution , hydrochloric acid , chromatography , phosphate buffered saline , dissolution testing , chemistry , biopharmaceutics classification system , inorganic chemistry , organic chemistry
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.