Newer rp-hplc method development and validation for the simultaneous estimultaneous estimation of fosnetupitant and palonosetron in dosage form

Abstract

A novel, precise, accurate, rapid and cost effective isocratic reversephase high performance liquid chromatographic (RP-HPLC) method was developed, optimized and validated for the estimation of Fosnetupitant and Palonosetron in bulk and pharmaceutical dosage forms. The drugs were estimated using Phenomenex Gemini C18 (4.6mm×150mm, 5µm) particle size column. A mobile phase composed of tri ethylamine buffer and methanol in proportion of 32:68 v/v, at a flow rate of 1.0 ml/min was used for the separation. Detection was carried out at 248nm. Precession studies showed % RSD values less than 2 % for both the drugs in all the selected concentrations. The percentage recoveries of Fosnetupitant and Palonosetron were found to be 100.1873% for Fosnetupitant and 100.748% for Palonosetron respectively. The assay results of Fosnetupitant and Palonosetron were found to be 99.82%. The limit of detection (LOD) and limit of quantification (LOQ) were 2.6µg/ml and 7.8µg/ml for Fosnetupitant and 3.4µg/ml 10.2µg/ml for Palonosetron respectively. The proposed method was validated as per the International Conference on Harmonization (ICH) guidelines. The proposed validated method was successfully used for the quantitative analysis of commercially available dosage form.