METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ALISKIREN AND ENALAPRIL IN BULK AND SYNTHETIC MIXTURE BY REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD.

A simple, rapid, precise and accurate high performance liquid chromatography method was developed for simultaneous estimation of enalapril and aliskiren in synthetic mixture. The separation was obtained using a mobile phase consisting of acetonitrile and water in ratio of 80:20 and adjusting pH 4.0 with ortho phosphoric acid (10%) using Phenomenex-luna C18 (250 × 4.6 mm, 5µm) column. The flow rate 1.0 mL min-1 and UV detection at 210 nm was employed. The retention time for enalapril and aliskiren was 2.63 min and 7.25 min respectively. Linearity for enalapril and aliskiren was found to be in the range of 2-10 µg/mL and 15-75 µg/mL respectively. The method was validated as per the ICH guidelines and the results were within the acceptance criteria for precision, linearity, specificity, stability of solution and robustness. [ABSTRACT FROM AUTHOR]