Abstract

DEVELOPMENT AND VALIDATION OF RASAGILINE MESYLATE ALONG WITH RILUZOLE FOR SIMULTANEOUS ESTIMATION BY HPLC METHOD

Chandrashekar Javali* and Tanaji

ABSTRACT

A simple, sensitive, precise, rapid and accurate reverse phase high performance liquid chromatographic method was established for the simultaneous estimation of Rasagiline mesylate and Riluzole using Acetonitrile: potassium dihydrogen ortho phosphate in milli pore water (60:40 v/v) at flow rate of 1.0mL/min. Lichrosphere C18 column (250×4.6mm,5μ) provided chromatographic separation of analyte followed by detection with UV at 264nm. The retention time of Rasagiline Mesylate and Riluzole was found to be 5.1 min and 4.3 min respectively. The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 50-250 μg/mL for Rasagiline Mesylate and 4-20 μg/mL for Riluzole. The mean values of the correlation coefficient were 0.999 for Rasagiline mesylate and 0.999 for Riluzole. The method was validated to fulfill international conference on harmonization (ICH) requirements with parameters such as linearity, specificity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, robustness and ruggedness. All the validation parameters were found to be well within the acceptance criteria. Hence the proposed method can be used for the routine analysis of Rasagiline Mesylate and riluzole in bulk and tablet dosage forms.

Keywords: Rasagiline mesylate, Riluzole, RP-HPLC, Simultaneous estimation. ICH guidelines.