Development and Validation of Related Substances Method for Febuxostat Tablets by RP-HPLC
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2017, Vol 5, Issue 3
Abstract
The present paper describes about highly sensitive, linear, precise, rugged, accurate and robust RP-HPLC method for determination of related substances present in Febuxostat tablets. Chromatographic separation with separation of impurities at satisfactory level was achieved using Exsil ODS-B (250 x 4.6 mm, 5µm) column by using gradient elution mode. Mobile phase-A consists of 0.1% v/v triethylamine in water and pH adjusted to 2.5 with orthophosphoric acid. 0.1%v/v orthophosphoric acid in (80:20) %v/v acetonitrile and methanol was used as mobile phaseB. Flow rate was kept at 1.0 ml/min with a monitoring wavelength of 315 nm. Developed method was successfully validated as per method validation parameters recommended by International Conference on Harmonisation (ICH) for specificity, LOQ, LOD, linearity, precision, accuracy, robustness and solution stability. The validated Reverse phase-High Performance Liquid Chromatography (RP-HPLC) method was successfully used for quantitative determination of related substances of Febuxostat tablets.
Authors and Affiliations
K. Ranjith, M. V. Basaveswara Rao, D. Rama Sekhara Reddy and T. E. G. K. Murthy
Keywords
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