VALIDATED SPECTROPHOTOMETRIC METHOD FOR THE QUANTITATION OF REBAMIPIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Bindhyashree K. M.*, Naveen Kumar G. S. and Sowmya H. G.

ABSTRACT

Simple, precise and accurate zero order derivative spectroscopic method has been developed and validated for the estimation of Rebamipide in bulk and pharmaceutical dosage form. The drug shows maximum absorption (λ max) at 235nm in 0.1 N sodium hydroxide and obeys Beer’s law in the concentration range of 1-6µg/ml. The linearity study was carried out and regression coefficient was found to be 0.999 and it has showed good linearity, precision during this concentration range. The percentage recovery was found to be 100.43 – 101.08. The LOD and LOQ were found to be 0.024 and 0.07µg/ml. The % relative standard deviation were found to be less than 2. According to ICH guidelines the technique has been validated for linearity, precision, accuracy, ruggedness, LOD and LOQ. The developed and validated method can be successfully applied for routine estimation of Rebamipide in bulk and pharmaceutical dosage form.

Keywords: Rebamipide, Zero order derivative spectroscopy, Validation, Pharmaceutical formulation.