versão impressa ISSN 0100-4042
MARQUES-MARINHO, Flávia Dias et al. Simvastatin assay and dissolution studies by feasible RP-HPLC in tablets. Quím. Nova [online]. 2012, vol.35, n.6, pp.1233-1238. ISSN 0100-4042. http://dx.doi.org/10.1590/S0100-40422012000600031.
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.
Palavras-chave : Simvastatin tablets; dissolution studies; RP-HPLC.