Development and validation of HPLC-UV method for the estimation of rebamipide in human plasma

Abstract

A simple, rapid, selective and sensitive reversed phase HPLC method was developed and validated for the determination of rebamipide from plasma. The drug was extracted with a mixture of chloroform and isopropyl alcohol. Rebamipide was measured in plasma using a validated HPLC method with UV detection at 280 nm. Chromatographic peaks were separated on a 5 µm C-18 silica column using a mixture of acetonitrile, water, methanol and acetic acid as a mobile phase. The chromatograms showed good resolution and no interference from plasma.The retention time of rebamipide and internal standard were approximately 4.9± ± ± ± ±0.3 min and 7.6± ± ± ± ±0.3 min, respectively. The mean recovery from human plasma was found to be above 91%. The method was linear over the concentration range of 10 to 500 ng/ml with coefficient of correlation (r 2) 0.991. Both intra-day and inter-day accuracy and precision data showed good reproducibility. This method can be successfully applied to pharmacokinetic studies.

Optimization of Forced Degradation Using Experimental Design and Development of a Stability-Indicating Liquid Chromatographic Assay Method for Rebamipide in Bulk and Tablet Dosage Form

“…Literature survey revealed very few quantitative analytical methods for estimation of rebamipide with bioanalytical applications [12–15]. Till date no stability-indicating HPLC method has been reported for quantification of rebamipide…”