Method development and validation for the estimation of rebamipide in api form and marketed formulation

Abstract

A new analytical, precise, accurate and rapid high performance liquid chromatographic method has been developed and validated for the estimation of Rebamipide in bulk form and marketed pharmaceutical dosage form. A Symmetry ODS (C18) RP Column, 250 mm x 4.6 mm, 5µm in isocratic mode, with mobile phase containing a mixture of Phosphate Buffer (0.02M): Acetonitrile in the ratio of 48:52 v/v (pH was adjusted to 2.80 with orthophosphoric acid) was used. The mobile phase was pumped at a flow rate of 1.0 ml/min and the eluents were monitored at 248 nm. The selected chromatographic conditions were found to effectively separate Rebamipide (Rt: 3.867min). The method was validated in terms of linearity, accuracy, precision, and specificity, limit of detection and limit of quantitation. Linearity for Rebamipide was found in the range of 30-70µg/ml. The percentage recoveries for Rebamipide ranged from 98%-120%. The limit of detection and the limit of quantitation for Rebamipide were found to be 0.09µg/ml and 0.027µg/ml respectively. The method was found to be robust and can be successfully used to determine the drug content of marketed formulations.