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Analysis of Atorvastatin and Related Substances by MEKC

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Abstract

A new micellar electrokinetic capillary chromatographic (MEKC) method has been developed for simultaneous quantitation of atorvastatin (AT) 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 AT as well as the peaks of neutral drug-related substances. Linear calibration curves were established over the concentration range 100–1,200 μg mL−1 for AT and 1.0–12.5 μg 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 AT and purity evaluation of bulk drug and formulated products.

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Acknowledgments

This work was supported through a grant (Investigation of new methods in analysis of drugs and bioactive substances) from the Ministry of Science, Education and Sports of the Republic of Croatia.

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Authors and Affiliations

  1. Department of Analytics and Control of Medicines, Faculty of Pharmacy and Biochemistry, University of Zagreb, 10 000, Zagreb, Croatia

    Biljana Nigović & Miranda Damić

  2. Faculty of Pharmacy, Institute of Pharmaceutical Biology, University of Ljubljana, 1000, Ljubljana, Slovenia

    Rade Injac, Nina Kočevar Glavač & Borut Štrukelj

Authors
  1. Biljana Nigović
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  2. Miranda Damić
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  3. Rade Injac
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  4. Nina Kočevar Glavač
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  5. Borut Štrukelj
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Correspondence to Biljana Nigović.

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Nigović, B., Damić, M., Injac, R. et al. Analysis of Atorvastatin and Related Substances by MEKC. Chroma 69, 1299–1305 (2009). https://doi.org/10.1365/s10337-009-1049-4

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  • DOI: https://doi.org/10.1365/s10337-009-1049-4

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