A Stability-Indicating UPLC Method for Simultaneous Quantification of Epalrestat and Pregabalin in Bulk and Marketed Formulations

Abstract

A specific, precise, rapid and reliable stability indicating UPLC method has been developed and validated for simultaneous separation and estimation of Epalrestat and Pregabalin in bulk drugs and marketed formulations. Chromatographic separation was achieved on a agilent Zorbax SB C18 (2.1 x 100mm, 1.8µm) column using isocratic mode of elution with 0.1% Formic acid and Acetonitrile in the ratio 60:40 v/v at a flow rate of 1.0 mL/min and analytes were monitored at 226nm. The retention times of Epalrestat and Pregabalin were about 0.97 and 1.27 minutes respectively. The developed method was validated for specificity, linearity, precision, accuracy, ruggedness and stress degradation studies were established. The results of specificity and stability studies indicate that there was no interference of diluent, excipients, and degradation products at respective retention times of analytes. The detector response was linear in the range of 10-150% level with respect to test concentration of Epalrestat and Pregabalin. Correlation coefficient (R2) was found not less than 0.999 for both analytes. The percentage assay of Epalrestat and Pregabalin were about 100.99% and 100.77% respectively. Hence, the developed method was rapid, specific, accurate and economical, and it can be used for routine analysis of these drugs in bulk and marketed formulations.