Fast Analysis of Statins in Pharmaceuticals by MEKC

Abstract

A universal micellar electrokinetic capillary chromatographic (MEKC) method with diode-array detection for the simultaneous and short-time analysis of lovastatin, simvastatin, pravastatin, fluvastatin, atorvastatin and rosuvastatin was introduced. Base hydrolysis was used to open lactone ring of lovastatin and simvastatin, administered as lactone prodrugs, in order to transform these compounds to the corresponding β-hydroxyl acid forms before MEKC analysis. This approach offered shorter analysis time due to a decrease of the migration times of negatively charged statin drugs in comparison to neutral lactone forms. Optimized conditions were found to be a 25 mM borate buffer pH 9.5 with 25 mM sodium dodecyl sulphate and 10% methanol added as an organic modifier, an applied voltage of 23 kV and a separation temperature of 30 °C. Ketoprofen was used as an internal standard. The linearity of the detector response for each statin was within the concentration range from 10 to 100 μg mL−1 with a correlation coefficient greater than 0.9994. Analyses of six statin drugs in pharmaceutical samples were carried out in only 5 min. The interference of the tablet sample matrix was not observed. The recovery values were in the range of 98.04–100.80%.