DEVELOPMENT AND VALIDATION OF REPAGLINIDE BY REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY(RP-HPLC) IN TABLET DOSAGE FORMS

Repaglinide is an oral antihyperglycemic agent used for the treatment of non-insulin-dependent diabetes mellitus (NIDDM). A new RP-HPLC method was developed for the estimation of Repaglinide which is simple and less time consuming using an economical column. The analysis was resolved by using a mobile phase (Potassium di hydrogen phosphate: Methanol (80:20)) at a flow rate of 1 ml per minute using ACE- C18 (250 x 4.0, 5 microns) on an isocratic HPLC system. There was no interference observed from other impurities and Repaglinide has been eluted with good peak shape, response within 12 minutes and retention time at 3.016 minutes. The detection was made at 285 nm.The assay of the sample has been carried out using this new method and it was found to be 99.7%. The developed method has been validated for different parameters like Specificity, Precision, Linearity, Accuracy, Robustness, Limit of Detection (LOD) and Limit of Quantitation(LOQ) are studied as reported in the International Conference on Harmonization (ICH) guidelines. All the results obtained were within the acceptance limits indicating that the developed method is simple, specific accurate and economical. The method may now be recommended for routine and quality control analysis of Repaglinide.