Simvastatin assay and dissolution studies by feasible RP-HPLC in tablets
AUTOR(ES)
Marques-Marinho, Flávia Dias, Santos, Amanda Leão dos, Vianna-Soares, Cristina Duarte, Reis, Ilka Afonso, Zanon, José Carlos da Costa, Lima, Angélica Alves
FONTE
Química Nova
DATA DE PUBLICAÇÃO
2012
RESUMO
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.
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