engleski

Determination of Atorvastatin and Related Impurities in Pharmaceuticals by Micellar Electrokinetic Chromatography

Capillary electrophoresis (CE) has a wide range of applications as an analytical technique, especially in pharmaceutical related analysis. The main advantages are high efficiency, short analysis time, high selectivity and low solvent consumption. CE is commonly used in drug development, quality control of peptide drugs, chiral separations, analysis of drugs and their metabolites in biological fluids, impurity profiling. A micellar electrokinetic capillary electrophoresis method was developed and validated for the simultaneous determination of atorvastatin and its impurities. Atorvastatin competitively inhibits the microsomal enzyme 3-hydroxy-3-methylglutaryl-co-enzyme A reductase and is a commonly used lipid-lowering drug. During method development various parameters, including the effects of buffer type and concentration, buffer pH, surfactant concentration, type and concentration of organic modifier, applied voltage, temperature and injection time were investigated. The optimized buffer was composed of 10 mM sodium tetraborate at pH 9.5, 50 mM sodium dodecyl sulfate and 20% (v/v) methanol. The separation of atorvastatin calcium and its four impurities was performed using a fused-silica capillary of 40 cm effective length (with a bubble cell, 150 μ m) at 25&ordm ; C, applied voltage was + 30 kV. The current did not exceed 40 μ A under these conditions. Injection was hydrodynamic at 50 mbar pressure for 10 s. The detection wavelength was set to 214 nm. The separation was carried out at positive polarity. Proposed method allows baseline separation of atorvastatin and its impurities (desfluoro atorvastatin, diastereomer of atorvastatin, atorvastatin methyl ester and atorvastatin lactone). The method was applied for analysis of two batches of the bulk drug provided by different manufactures and pharmaceutical dosage forms.

Capillary electrophoresis; micellar electrokinetic chromatography; atorvastatin; related substances; pharmaceuticals

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