статины

Statins, key drugs for the prevention of cardiovascular disease, are represented by a number of structurally diverse compounds requiring reliable identifi cation methods to ensure their quality control. This study, for the fi rst time, provides a comprehensive comparative analysis of all commercially signifi cant statins (lovastatin, simvastatin, pravastatin, fl uvastatin, atorvastatin, rosuvastatin, and pitavastatin) using complementary spectral methods: UV, FTIR (ATR), ¹H NMR spectroscopy, and mass spectrometry.

The influence of a number of factors on the chromatographic properties of statins (atorvastatin, rosuvastatin, simvastatin) in normal-phase and reverse-phase chromatography modes has been studied by the method of the thin-layer chromatography (TLC) in order to select the most effective analytical systems for the total and separate determination of statins in pharmaceuticals. The study has been performed by ascending TLC on commercial plates with polar, weakly polar, and nonpolar phases.

The chromatographic behavior of atorvastatin, rosuvastatin and simvastatin in the presence of the main modifi ers of the mobile phase: elution strength and buff er solution, has been studied by means of the reverse-phase high-performance liquid chromatography (HPLC) method. Optimal modifi cation conditions have been found and their application for the determination of statins under study in the pharmaceutical preparations Atorvastatin-OBL, Liprimar and Tulip has been shown. The Sr value is 0.03. The relative determination error does not exceed 7%.