Abstract

DEVELOPMENT AND VALIDATION OF RAPID RP- HPLC METHOD FOR THE DETERMINATION OF FEBUXOSTAT (A NON-PURINE SELECTIVE XANTHINE-OXIDASE/XANTHINE-DEHYDROGENASE INHIBITOR) IN BULK AND PHARMACEUTICAL DOSAGE FORM

Ravisankar P*, Anusha Rani K, Venkata Ramana K, Gowthami S

ABSTRACT

An accurate, highly sensitive, efficient, precise and reproducible, isocratic reverse phase High Performance Liquid Chromatography method was developed and validated for the quantitative determination of Febuxostat in pharmaceutical tablet dosage forms. The separation was achieved by using Shimadzu LC-20AT Prominence Liquid Chromatograph having a Welchrom C18 isocratic column, (250 mm × 4.6 mm i.d., particle size 5 μm, maintained at ambient temperature) used as stationary phase. Acetonitrile: Water (50:50 v/v), adjusted to pH 3.3 by using ortho phosphoric acid and triethylamine as column modifier. The flow rate was set to 1.0 mL/minutes. The wavelength was determined at 240 nm using Shimadzu SPDSPDSPD-20A prominence UV 20A prominence UV20A prominence UV 20A prominence UV 20A prominence UV 20A prominence UV 20A prominence UV20A prominence UV20A prominence UV -Vis detector. Vis detector. Vis detector. Vis detector. Vis detector. Vis detector. The retention time of Febuxostat was found to be 8.737 minutes. Linearity was recognized for Febuxostat in the range of 1-5 μg/mL with correlation coefficient 0.999. The method was accurate and precise with recoveries in the range of 99.81 - 99.945 % and relative standard deviation < 2 %. Validation parameters such as specificity, linearity, precision, accuracy, and robustness, limit of detection (LOD) and limit of quantitation (LOQ) were evaluated. The projected methods were validated according to International Conference on Harmonization ICH Q2 (R1) guidelines. The developed method was successfully applied for the quantitative analysis of commercially available dosage form.

Keywords: RP - HPLC, Febuxostat, Validation, ICH guidelines.