Stability Indicating RP-HPLC Method Development and Validation for Estimation of Diroximel Fumarate in bulk and its dosage forms

Abstract

Aim and objective: The aim of present research work is to develop validated RP-HPLC stability indicating method for the quantification of Diroximel Fumarate in bulk and its pharmaceutical dosage forms. Materials and methods: Chromatographic method was carried on C18 column (Waters 250mm x 4.6mm, 5m). Mobile phase was prepared by mixing water: Acetonitrile: 85% OPA: in the ratio of 70:30. The flow rate was 0.1 mL/min and the injection volume was 20μL. The absorbance maxima of Diroximel Fumarate was measured at 215nm. The retention time was found to be 2.390 min. Result: The method was proved to be specific and linear in the range of 50-150μg/mL with correlation coefficient of 0.999. The % RSD for precision was found to be less than 2% and the mean percentage recovery was 100.15%. All the validation parameters were statistically validated according to ICH guidelines and were found to be within acceptance criteria. Conclusion: The developed method was simple, specific, precise, accurate and robust. The described HPLC method can be successfully employed for the analysis of Diroximel Fumarate.