METHOD DEVELOPMENT, VALIDATION AND STABILITY STUDY OF REPAGLINIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY UV SPECTROMETRIC METHOD
A simple method for the estimation of Repaglinide in bulk and pharmaceutical dosage forms has been developed. Methanol was chosen as the solvent system. The λmax was found to be 237nm. The responses were linear in the range of 10- 90µg/ml. The regression equation of the calibration graph and correlation coefficient were found to be y = 0.026x - 0.001 and 0.999 respectively. The %RSD values for both intraday and interday precision were less than 1%. The recovery of the drug from the sample was ranged between 99.62% and 100.49%. The proposed method was validated for precision, accuracy, intraday and interday assay. Commercial tablets containing 2mg of Repaglinide were analyzed by the proposed method and the results were well within the claimed limits. Further stability studies of Repaglinide were carried out under acidic, alkaline, hydrolytic and photolytic conditions as per SIAM (Stability Indicating Assay Methods).