A New HPLC Method for Determination of Ropinirole in Human Plasma and its Application in Bioequivalence Studies

N. Adib¹, M. Shekarchi¹* and A. Dabirsiaghi²

¹Food and Drug Lab Research Center, Ministry of Health, Tehran Iran

²Azad University of Medicinal Sciences, School of Pharmacy, Pharmaceutics Department, Tehran Iran.

ABSTRACT: A simple, rapid and sensitive isocratic reversed-phase high performance liquid chromatography method for the determination of ropinirole in human plasma has been developed. After protein precipitation with water-methanol (50:50 v/v), quinidine and phosphate buffer were added, shacked for 10 min, centrifuged at 3500 rpm for 5 min and evaporated in 40oC. The residual was dissolved in mobile phase and injected to HPLC. Chromatographic analysis of ropinirole in plasma was achieved on a μ-bondapack C18 column (150×4.6 mm, 5μ) using methanol- trifluoroacetic acid 0.1% (78: 22) mixture, as mobile phase. The flow rate was set at 1 ml/min and the detection was performed at 250 nm. The lower limit of detection was 0.2 ng/ml and lower limit of quantization was 0.5 ng/ml. The intra and inter-day precisions (CV %) of the quality control samples were 1.11-3.58 and 2.42- 3.89% respectively. The recovery of method was %97.05±0.68. The method was applied to a bioequivalence study in human.

KEYWORDS: Ropinirole; Human plasma; HPLC; Bioequivalence

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