Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR THE ESTIMATION OF REBAMIPIDE IN BULK AND TABLET DOSAGE FORM

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

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Abstract

Simple, precise and accurate area under curve spectroscopic method has been developed and validated for the estimation of Rebamipide in bulk and pharmaceutical dosage form. The drug shows maximum absorption (λmax) at 235nm in 0.1N NaOH solution and Area under Curve [AUC] in absorption spectra were measured between the wavelength range 230 to 240nm which obeys Beer’s law in the concentration range of 1-6μg/ml. The linearity study carried and regression coefficient was found to be 0.9992 and it has showed good linearity, precision during this concentration range. The % recovery was found to be 98.5-100.2. The LOD and LOQ were found to be 0.06 and 0.18μg/ml. The % relative standard deviation were found less than 2. According to ICH guidelines the method has been validated for linearity, precision, accuracy, robustness, ruggedness, LOD and LOQ. The developed and validated method can be successfully applied for reliable quantification of Rebamipide in bulk form and pharmaceutical dosage form.

Keywords: Rebamipide, Area under curve spectroscopy, validation, pharmaceutical formulations.