Stability Indicating Method Development and Validation for Simultaneous Estimation of the Netupitant and Palonosetron in Bulk and Pharmaceutical Dosage Form by RP-HPLC

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Netupitant and Palonosetron in Pharmaceutical dosage form. Chromatogram was run through Phenomenex C18 150 mm (4.6 x 150mm, 5μm) Mobile phase containing Buffer 60% 0.01N KH2PO4: 40% Acetonitrile was pumped through column at a flow rate of 1 ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 230.0 nm. Retention time of Palonosetron and Netupitant were found to be 2.266 min and 2.945 min. %RSD of the Netupitant and Palonosetron were and found to be 0.8 and 0.8 respectively. %Recovery was obtained as 101.08% and 100.35%for Netupitant and Palonosetron respectively. LOD, LOQ values obtained from regression equations of Netupitant and Palonosetron were 1.27, 3.86 and 0.002, 0.006. respectively. Regression equation of Netupitant is y =18431x + 50471.and y = 13091x + 11.98. of Palonosetron. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.