LAUSR

BACKGROUND Rebamipide (REB) is quinolinone derivative compound, which is used for treatment of stomach ulcers. OBJECTIVE Four Spectrophotometric methods are developed for quantification of REB and its impurity and degradation product; the debenzoylated isomer of Rebamipide (DER). METHODS Method A is ratio difference spectrophotometry (RD) where 254 and 291 nm were selected for REB and 320 and 355 nm were selected for DER, allowing spectral discrimination for both. Method B is derivative ratio spectrophotometry (DD1), where peak amplitude of first derivative of ratio spectra at 261 and 350.2 nm for REB and DER, respectively, are determined. Method C is a second derivative (D2) approach, which allows quantification of both REB and DER at 337 and 340 nm, respectively. Method D is mean centring of ratio spectra (MC), where electronic absorption spectra of REB and DER were recorded and divided by a suitable divisor from DER and REB, respectively, and then mean centre is represented by ratio spectrum so obtained. RESULTS The proposed methods are simple, selective, and sensitive in the quantification of the REB and DER. These methods were validated according to ICH guidelines. Statistical analyses performed on the findings from suggested methods and those obtained from reported method revealed high accuracy and good precision. CONCLUSION The developed and validated methods are useful methods for quality control assay in routine analysis. HIGHLIGHTS First derivative, second derivative, derivative ratio and mean centring methods for quantification of REM and DER. These methods are useful for analysis of REB in pharmaceutical dosage form.