Abstract

STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF PREGABALIN AND EPALRESTAT

G. Indira Priyadarshini*, K. Hadassa, Nagaraju Pappula and V. Mounika

Abstract

A simple, precise, accurate, rapid, robust and economical RP-HPLC method was developed and validated for the assay of Epalrestat and Pregabalin in tablet formulation. This method yielded high recoveries with good linearity and precision. The method was developed using WATERS HPLC 2965 SYSTEM with Auto Injector and PDA 2996 Detector. Software used is Empower 2. Discovery (250 x 4.6 mm, 5μ) column is used as stationary phase with mobile phase containing mixture of buffer: acetonitrile, 50:50 (v/v). The eluted compound was monitored at 241 nm. The developed method was validated for parameters of Specificity, Linearity, Precision, Accuracy, Limit of Detection, Limit of Quantification and Robustness as per approved ICH guidelines. The results obtained after the analysis of drug by the proposed validation parameters were highly reproducible and reliable. The %Assay of Epalrestat and Pregabalin by the proposed method was found to be 98.0%-99.0%. The %RSD of the drug was found to be 0.7 & 0.6 which are within limit. The validation parameters results of the drug were found to be within limit.

Keywords: RP-HPLC method, Validation, Epalrestat and Pregabalin.