DEVELOPMENT OF A NEW LC METHOD FOR THE IDENTIFICATION, SEPARATION AND ASSAY OF SIMVASTATIN AND ITS IMPURITIES
IOANA DRĂGHICI, CORINA ARAMĂ*, ANGELA NEDELCU, CRINA-MARIA MONCIU, MIHAI STĂNESCU, CRISTIAN TUCHILĂ
Faculty of Pharmacy, University of Medicine and Pharmacy Carol Davila, Bucharest, Romania
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The new method described below, RP-HPLC (reversed phase - high performance
liquid chromatography) on a cyanopropyl column, is a convenient and efficient but less
explored alternative method for the separation and quantification of simvastatin and its
impurities. The critical parameters for the newly developed method were studied, the final
purpose being suitability assesment for the analysis of pharmaceutical dosage forms
containing simvastastin.
The optimum experimental conditions (Nucleosil column 100-5CN 125 x 4.6
mm i.d, with 5 μm particles, gradient elution with a mixture of water and acetonitrile; room
temperature; 2.5 mL/min flow rate; UV detection-238 nm) for the separation and assay of
simvastatin were established.
