Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION FEBUXOSTAT RELATED SUBSTANCES IN BULK AND FORMULATIONS

Dr. G. Abirami* and Dr. T. Vetrichelvan

Abstract

A novel simple RP-HPLC method has been developed for the estimation of Febuxostat related substances in bulk and formulations. The impurities observed in the Febuxostat API were amide impurity, Acid impurity, Secondary - butoxy acid impurity, Tertiary- butoxy acid impurity and ECI (Ethyl2-(3-cyano-4-isobutoxy phenyl) 4- methylthiazole-5-carboxylate) impurity. Ortho phosphoric acid (0.1%) as mobile phase – A, Methanol: Acetonitrile as (85: 15 v/v) mobile phase- B followed by gradient elution was confirmed by number of trials. The method was developed on kromosil C18 column (250mm×5mm, 4.6μm). Febuxostat peak was eluted at 22 min and other impurities at their respective retention times. The developed method was validated as per ICH guidelines parameters like Accuracy, Linearity, LOD, LOQ and robustness were performed. The drug and all other impurities were linear at about 0.15-1.125 μg/ml range. The method was satisfied by all the validation parameters and suitable for the estimation Febuxostat related substances in routine analysis.

Keywords: Febuxostat, related substances, method development, validation, Kromosil C18 column and RP-HPLC.