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Analysis of Atorvastatin and Related Substances by Micellar Electrokinetic Capillary Chromatography

A new micellar electrokinetic capillary chromatographic (MEKC) method has been developed for simultaneous quantitation of atorvastatin and its related substances. The separation was carried out in an extended light path capillary at applied voltage of 30 kV using a background electrolyte consisting of 10 mM sodium tetraborate buffer pH 9.5, 50 mM sodium dodecyl sulphate and 20% (v/v) methanol. The addition of methanol to the running buffer resulted in a very effective choice to achieve resolution between the peaks of charged substances adjacent to atorvastatin as well as the peaks of neutral drug-related substances. Linear calibration curves were established over the concentration range 100-1200 µ ; ; g mL-1 for atorvastatin and 1.0-12.5 µ ; ; g mL-1 for related substances. The proposed MEKC procedure has been validated with respect to selectivity, precision, linearity, limits of detection, and quantitation, accuracy and robustness. The method has been successfully applied to the determination of atorvastatin and purity evaluation of bulk drug and formulated products.

Atorvastatin; Micellar electrokinetic capillary chromatography; Related substances; Pharmaceuticals

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