Simvastatin assay and dissolution studies by feasible RP-HPLC in tablets

oleh: Flávia Dias Marques-Marinho, Amanda Leão dos Santos, Cristina Duarte Vianna-Soares, Ilka Afonso Reis, José Carlos da Costa Zanon, Angélica Alves Lima

Format: Article
Diterbitkan: Sociedade Brasileira de Química 2012-01-01

Deskripsi

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.