Abstract

A high performance liquid chromatography (HPLC) method was developed for the simultaneous determination of rosiglitazone and gemfibrozil in human plasma using α-asarone as an internal standard (IS). Plasma samples were pretreated by protein precipitation. The analytes were separated on a Macherey–Nagel Nucleodur C 18 (250 mm × 4.6 mm, 5 μm) column using acetonitrile and 30 mmol/l ammonium acetate solution (including 0.1% methanoic acid) as mobile phase which was delivered at 1.2 ml/min. A gradient elution program was adopted to adjust proportion of solvent in mobile phase. A time program was used to regulate conditions of fluorescence detection. The method was validated over the concentration range of 5.0–751.3 ng/ml for rosiglitazone and 0.5–75.4 μg/ml for gemfibrozil with acceptable accuracy, precision and extraction recoveries. This method is suitable for routine therapeutic drug monitoring and pharmacokinetic interaction study of the two drugs.

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