A New HPLC Method for Determination of Repaglinide in Human Plasma and Its Application in Bioequivalence Studies  

N. Adib¹, M. Shekarchi¹*, A. Dabirsiaghi², H. Hajimehdipoor¹, H. Rastegar¹ and B. Akbari- Adergani¹

¹Food and Drug Lab Research Center, Ministry of Health, Tehran Iran. ²Department of Pharmaceutics, School of Pharmacy, Azad University of Medicinal Sciences, Tehran Iran.

ABSTRACT: A simple, rapid and sensitive isocratic reversed-phase high performance liquid chromatography method for the determination of repaglinide in human plasma has been developed. After protein precipitation with acetonitrile chromatographic analysis of repaglinide in plasma was achieved on a μ-bondapack C18 column using acetonitrile- methanol- potassium dihydrogen phosphate 0.01 M (51: 11: 38) mixture, pH 2.5, as mobile phase. The flow rate was set at 1.5 ml/min and the emission and excitation were 348 and 244 respectively. The lower limit of detection was 1 ng/ml and lower limit of quantization was 5ng/ml. The intra and inter-day precisions (CV %) of the quality control samples were 1.43- 3.29 and 1.14- 4.11% respectively. The recovery of method was %98.3 ± 1.08. The method was applied to a bioequivalence study in human.

KEYWORDS: Repaglinide; Human plasma; HPLC; Bioequivalence

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