RP- HPLC Study Of Rebamipide.

      Аннотация: The aim of the present work was to develop and validate a simple RP-HPLC method for the determination of Rebamipide. Chromatographic separation of Rebamipide was achieved by using a C18 column. A Mobile phase containing a mixture of methanol: water (70:30 v/v) was pumped at the flow rate of 1 ml/min. Detection was performed at 231 nm. Validation parameters were evaluated according to the International Conference on Harmonization (ICH) Q2R1 guidelines. The calibration curve was linear in the concentration range 2- 10?g/ml for the Rebamipide with regression coefficient 0.999. The method was found to be accurate with 0.66 % RSD. RSD values were found to be 0.94 % in the case of intra-day precision studies,whereas0.76% in the case of inter-day precision the limits of detection and quantification were found to be 0.6, 1.98?g/ml, respectively. The results obtained from the stress testing reveals that Rebamipide drug substance is particularly stable under acidic, neutral and thermal degradation conditions. From the stability point of view, care should be taken in the manufacturing process and storage of this product.

Ключевые слова: Rebamipide, RP-HPLC method development, stability studies, ICH guideline