ABSTRACT:
The present study describes about novel approach to develop and validate a rapid, accurate, precise, simple, efficient and reproducible isocratic Reversed Phase-High Performance Liquid Chromatographic (RP-HPLC-DAD) method for the estimation of Eluxadoline in bulk and pharmaceutical dosage form. Eluxadoline were separated using Hypersil C18 column (250mm×4.6 mm, 5micrometer particle size), Waters Alliance e2695 HPLC system with 2998 PDA detector and the mobile phase contained a mixture of Acetonitrile and Water (70:30, v/v). The flow rate was set to 1ml/min with the responses measured at 260nm. The retention time of Eluxadoline was found to be 3.481min.Linearity was established for Eluxadoline in the range of 10-125µg/ml with correlation coefficient (r2=0.999). The percentage recoveries were between 99.92% to 100.07%. Validation parameters such as specificity, linearity, precision, accuracy, robustness, limit of detection (LOD) and limit of quantitation (LOQ) were evaluated for the method according to the International Conference on Harmonization (ICH) Q2 R1 guidelines. The developed method was successfully applied for the quantification and hyphenated instrumental analysis.