The objective of this study was to develop and validate a method for simultaneous quantitative analysis
of allopurinol and lesinurad in bulk drug and pharmaceutical formulations. An isocratic HPLC analysis
method using a reverse phase Waters spherisorb ODS1 C18 column (250 mm × 4.6 mm, 5 μ) and a
simple mobile phase without buffer was developed, optimized and fully validated. Analyses were
carried out at a flow rate of 0.9 mL/min at 50 °C and monitored at 246 nm. This HPLC method
exhibited good linearity, accuracy and selectivity. The recovery (accuracy) of both allopurinol and
lesinurad from all matrices was greater than 98 %. The allopurinol and lesinurad peak detected in the
samples of a forced degradation study and no interference of excepients or the degradation products
formed during stress study. The method was rugged with good intra- and inter-day precision and
sensitive. This stability indicating HPLC method was selective, accurate and precise for the simultaneous
analysis of allopurinol and lesinurad in pharmaceutical formulations.