A novel RP-HPLC method development and validation for determination and estimation of eluxadoline drug with its impurities

Abstract

A Novel, efficient and convenient reversed-phase high-performance liquid chromatography method was developed for eluxadoline (EXDL) drug in the presence of its impurities 1 and 4. Successful separation of EXDL drug from the its impurities was achieved on Prontosil ODS C18 column (5 µm 250 × 4 mm) with isocratic elution of Acetonitrile:Methanol:0.1 M Sodium acetate 40:40:20 (v/v) as a mobile phase. The Ultraviolet detection was monitored at a wavelength of 246 nm at flow rate 1.0 mL/min. The validation of proposed method was carried for linearity, precision, accuracy, limit of detection, limit of quantification and robustness were determined in accordance with ICH guidelines. The method has good specificity and specified impurities can be effectively separated with god resolution. The proposed method is found to have linearity in the 100–600 μg/mL concentration range of EXDL with correlation coefficients of not less than 0.997 and 1–6 μg/mL for impurity 4 and 1 with 0.994, 0.997 correlation coefficients respectively. The compounds analyzed in the solutions are stable for at least 32 h. The limit of detection and the limit of quantification for the analytes are 0.25 μg/mL, 25 µg/mL and 0.25 μg/mL respectively. The method successfully estimated the drug in formulation tablet ad detected the impurities. The proposed method can be applied for quality control assay of EXDL, with the advantages of simplicity, accuracy, robustness, good selectivity, and high sensitivity.