Simultaneous determination of ezetimibe and simvastatin in pharmaceutical formulations by dual-mode gradient LC

OEZALTIN N., Ucaktuerk E.

CHROMATOGRAPHIA, vol.66, 2007 (SCI-Expanded) identifier identifier

  • Publication Type: Article / Article
  • Volume: 66
  • Publication Date: 2007
  • Doi Number: 10.1365/s10337-007-0303-x
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Hacettepe University Affiliated: Yes


A liquid chromatography method was developed and validated for the simultaneous determination of ezetimibe and sirrivastatin in pharmaceutical formulations. Optimum separation was achieved in less than 10min using a C-8 column (200 min x 4.6 mm i.d., particle size 5 pm) and elution was accomplished by the application of a dual-mode solvent and flow-rate gradient system. Detection was carried out using a diode-array detector set at 240 rim. Canrenone was used as internal standard. The method was economical in terms of the time taken and the amount of solvent used for each analysis. It was also validated with respect to system suitability, specificity, limit of quantitation and detection, linearity, precision, accuracy, and recovery, respectively. The limits of quantitation for ezetimibe and sirrivastatin were 0.2 and 3 mu g mL(-1), respectively. Limits of detections were found to be 0.05 and 0.5 mu g mL(-1), for ezetimibe and sirrivastatin, respectively. The developed method was successfully applied to the simultaneous determination of ezetimibe and simvastatin in pharmaceutical formulations.