Objective: A stability-indicating reversed-phase high-performance liquid chromatography (Rp-HPLC) method with a high sensitivity was developed for the validation of stability of Netupitant and Palonosetron in bulk and pharmaceutical dosage form. Methods: The chromatographic separation was achieved on Luna Phenyl Hexyl (250mm×4.6mm, 5mm particle size), Waters Alliance 2695 HPLC system with 2998 PDA detector and the mobile phase contained a mixture of 0.01M Triehylamine buffer (pH adjusted to 2.5 with orthophosphoric acid) and Acetonitrile (60:40, v/v). The flow rate was set to 1ml/min with the responses measured at 222nm. The reversed-phase HPLC method has been validated as per International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines to determine Netupitant and Palonosetron in pharmaceutical dosage form. Results: The proposed method showed a good linearity in the concentration range of 120.04-900.30μg/ml for h Netupitant and 0.12-1.56μg/ml for Palonosetron under optimized conditions. The statistical performance of the fully validated HPLC method and the performance results of the proposed HPLC method were considerably satisfactory with reference to the RSD values of validation parameters like linearity, system precision, method precision, robustness, rugdness etc.,. The validated method was successfully applied to quantify the Netupitant and Palonosetron in tablet form, and the corresponding recovery value was found to be 100 % for both Netupitant and Palonosetron. Conclusions: The validated HPLC method is one of the promising alternative analytical tool for routine analysis of Netupitant and Palonosetron in pharmaceutical samples.
Kusuma Jogi et al, 2017,A novel validated rp-hplc method for the simultaneous estimation of netupitant and palonosetron in bulk and pharmaceutical dosage form, International Journal of Current Science and Technology, Vol.5, Issue, 1, pp.317-323