A new HPLC Method for Determination of Carvedilol in Human Plasma and its Application in Bioequivalence Studies
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A simple, rapid and sensitive isocratic reversed-phase high performance liquid chromatography method for the determination of carvedilol in human plasma has been developed. After extraction with methanol chromatographic analysis of carvedilol in plasma was achieved on a μ-bondapack C18 column using acetonitrile- potassium dihydrogen phosphate (30: 70v/v) mixture, pH 2, as mobile phase. The flow rate was set at 1 ml/min and the emission and excitation were 350 and 238 respectively. The lower limit of detection was 0.05 ng/ml and lower limit of quantization was 0.2ng/ml. The intra and inter-day precisions (CV %) of the quality control samples were 2.45- 7.27 and 0.52-7.92% respectively. The recovery of method was %99.48±8.5. The method was applied to a bioequivalence study in human.
KEYWORDS:Carvedilol; Human plasma; HPLC; Bioequivalence
