Development and validation of a simple and fast HPLC method for determination of lovastatin, pravastatin and simvastatin

J Chromatogr Sci. 2012 Oct;50(9):831-8. doi: 10.1093/chromsci/bms079. Epub 2012 Jun 11.

Abstract

Statins are effective and often-prescribed drugs for the treatment of hypercholesterolemia. This study shows a simple and fast method validation by reversed-phase high-performance liquid chromatography in the linear range 28 to 52 µg/mL to quantify lovastatin, pravastatin sodium or simvastatin in bulk drug or dosage forms. Statins were determined using a C8 endcapped column (250 × 4 mm, 5 µm), isocratic mobile phase of acetonitrile and 0.1% phosphoric acid (65:35), 30°C, ultraviolet-diode array detection at λ 238 nm and 1.5 mL/min flow for lovastatin and simvastatin and 1.0 mL/min for pravastatin sodium. The developed method is fast, simple, reliable and shows appropriate linearity (r > 0.999), accuracy (98.8-101.6%), precision (relative standard deviation <2%) and selectivity toward placebo and/or degradation products in very similar chromatographic conditions for all statins.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Chromatography, High Pressure Liquid / methods*
  • Drug Stability
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / analysis*
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / chemistry
  • Linear Models
  • Lovastatin / analysis
  • Lovastatin / chemistry
  • Naphthalenes / analysis*
  • Naphthalenes / chemistry
  • Pravastatin / analysis
  • Pravastatin / chemistry
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Simvastatin / analysis
  • Simvastatin / chemistry

Substances

  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Naphthalenes
  • Lovastatin
  • Simvastatin
  • Pravastatin