Dissolution Test for Mianserin Hydrochloride in Tablets

Letícia Lenz Sfair; Caren Gobetti; Martin Steppe; Elfrides Eva Schermann Schapoval

doi:10.22456/2527-2616.97029

Authors

Letícia Lenz Sfair Escola de Saúde, Curso de Farmácia - Universidade do Vale do Rio dos Sinos
Caren Gobetti Faculdade de Farmácia - Universidade Federal do Rio Grande do Sul
Martin Steppe Faculdade de Farmácia - Universidade Federal do Rio Grande do Sul
Elfrides Eva Schermann Schapoval Faculdade de Farmácia - Universidade Federal do Rio Grande do Sul

DOI:

https://doi.org/10.22456/2527-2616.97029

Keywords:

Mianserin hydrochloride, Dissolution test, UV method, Quality control, IVIVC

Abstract

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.

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