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Determination of atorvastatin in human serum by reversed-phase high-performance liquid chromatography with UV detection.

Bahrami G, Mohammadi B, Mirzaeei S, Kiani A

Medical Biology Research Center, Medical School, Karmanshah University of Medical Sciences, Kermanshah 6714869914, Iran; School of Pharmacy, Kermanshah University of Medical Sciences, Kermanshah, Iran. gbahrami@kums.ac.ir

A rapid and sensitive high-performance liquid chromatographic method was validated and described for determination of atorvastatin in human serum. Following liquid-liquid extraction of the drug and an internal standard (sodium diclofenac), chromatographic separation was accomplished using C18 analytical column with a mobile phase consisting of sodium phosphate buffer (0.05 M, pH 4.0) and methanol (33:67, v/v). Atorvastatin and the internal standard were detected by ultraviolet absorbance at 247 nm. The average recoveries of the drug and internal standard were 95 and 80%, respectively. The lower limits of detection and quantification were 1 and 4 ng/ml, respectively, and the calibration curves were linear over a concentration range of 4-256 ng/ml of atorvastatin in human serum. The analysis performance was studied and the method was applied in a randomized cross-over bioequivalence study of two different atorvastatin preparations in 12 healthy volunteers.

Published 17 October 2005 in J Chromatogr B Analyt Technol Biomed Life Sci, 826(1): 41-5.
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