Abstract
A novel high speed, high resolution Reverse phase-UPLC method was developed for the quantification of related substances in Febuxostat drug substance. The separation of drug from the possible impurities was achieved on a Halo C18 column. The innovative approach of using stationary phase with sub 2 μ particles provides a comprehensive combination of selectivity and speed. 10 mM mono basic potassium phosphate buffer at pH 2.7 and acetonitrile mixture was selected as mobile phase. Flow rate and detection were kept at 0.8 mL/min and 320 nm respectively. The developed UPLC method was subjected to validation parameters. System precision, accuracy, specificity, limit of detection, limit of quantification and linearity were established as per the guidelines recommended by ICH. Stability indicating nature of the method was also performed by exposing the sample under various conditions like acid, base, peroxide and photo stability exposures. Total analysis run time 7.0 minutes indicates the speed and cost saving initiation of the developed method. Using the method one can carry out the quantitative estimation of related substances in Febuxostat drug substance, further the same method can be adopted for determination of drug substance assay also.
Highlights
Febuxostat is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout [1]
As per the literature Febuxostat Determination was done by spectrophotometric method [2] and RP-HPLC [3,4] methods
The aim of this paper is to develop a cost effective and fast method
Summary
Febuxostat is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout [1]. The primary mode of action of a xanthine oxidase inhibitor, achieves its therapeutic effect by decreasing serum uric acid.The objective of this work was to develop a cost effective ultra fast reverse phase UPLC method, the developed method was validated as per regulatory guidelines and transfer the method to quality control lab for analysis of related substances in Febuxostat. LC-MS/MS [5,6,7] assay method was proposed for bioequivalence and pharmacokinetics evaluation. Since this drug is being marketed in domestic and international market the present investigation by the author was to develop a rapid, accurate and precise RP-UPLC method [8,9,10] for the determination of related substances. The method was subjected to validation according to ICH requirements [17,18] (Figure 1)
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