Autor(es): Marinho, Flávia Dias Marques ; Santos, Amanda Leão dos ; Soares, Cristina Duarte Vianna ; Reis, Ilka Afonso ; Zanon, José Carlos da Costa ; Lima, Angélica Alves
Data: 2014
Origem: Oasisbr
Assunto(s): Simvastatin tablets; Dissolution studies
Commonly used HPLC acetonitrile solvent has been through a worldwide shortage with a cost increase in 2008 and 2009. In order to get around this situation, a method by RP-HPLC employing methanol and aqueous acid mobile phase was developed and validated to evaluate simvastatin. The quality control assay and dissolution studies of this lipid-lowering drug were performed in diluents methanol and 0.01 M phosphate buffer with 0.5% SDS, pH 7, respectively. Dissolution test aliquots did not go through sample treatment, as described in USP SIM tablets monograph by ultraviolet spectrophotometry. The proposed method is fast, simple, feasible and robust.
