Química Nova (Jan 2012)

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

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

DOI
https://doi.org/10.1590/S0100-40422012000600031
Journal volume & issue
Vol. 35, no. 6
pp. 1233 – 1238

Abstract

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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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