A NEW VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR THE QUANTIFICATION OF ALLOPURINOL AND LESINURAD IN BULK AND PHARMACEUTICAL FORMULATIONS

Abstract

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 x 4.6 mm, 5μ) 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 Lesinuradpeak 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 interday precision and sensitive. This stability indicating HPLC method was selective, accurate, and precise for the simultaneous analysis of Allopurinol and Lesinurad in pharmaceutical formulations.