Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF FOSNETUPITANT AND PALONOSETRON IN BULK AND COMBINED FORMULATION

Arshiya Kousar* and M. A. Haneef

Abstract

A novel approach was used to develop and validate a rapid, accurate, precise, simple, efficient and reproducible isocratic Reversed Phase-High Performance Liquid Chromatographic (RP-HPLC-DAD) method for the simultaneous estimation of Palonosetron and Fosnetupitant in bulk and pharmaceutical dosage form. Palonosetron and Fosnetupitant was separated using Altima C18 column (250mm×4.6mm, 5mm particle size), Waters Alliance 2695 HPLC system with 2998 PDA detector and the mobile phase contained a mixture of Methanol: TEA buffer (pH adjusted to 4.5 with orthophosphoric acid) and Acetonitrile (50:25:25 v/v). The flow rate was set to 1ml/min with the responses measured at 225nm. The retention time of Palonosetron and Fosnetupitant was found to be 2.1 min and 3.5 min respectively with resolution of 8.08. Linearity was established for Palonosetron and Fosnetupitant in the range of 5-25µg/ml for FFosnetupitant and 12.5 - 62.5 µg/ml for Palonosetron with correlation coefficients (r2 =0.999). The percentage recoveries were between 99.85% to 100.04% and 99.73% to 100.03% for Palonosetron and Fosnetupitant respectively. RP-HPLC method for the simultaneous estimation of Palonosetron and Fosnetupitant in their combine dosage form was established and validated as per the ICH guidelines. Palonosetron and Fosnetupitant are more sensitive towards acidic degradation condition and moderate degradation towards alkaline, thermal and very much resistant towards oxidative, photolytic and water degradation. The developed method was successfully applied for the quantification of Palonosetron and Fosnetupitant in bulk and pharmaceutical dosage form.

Keywords: Palonosetron and Fosnetupitant RP-HPLC-DAD, ICH.