European Journal of Biomedical and Pharmaceutical Sciences

SIMULTANEOUS QUANTITATIVE ESTIMATION OF NETUPITANT AND PALONOSETRON HCl BY HPTLC METHOD: DEVELOPMENT AND VALIDATION.

Vasava Shilpa N. and Rajashree C. Mashru*

ABSTRACT

A simple, selective, precise High-performance thin-layer chromatographic method for simultaneous estimation of Palonosetron hydrochloride and Netupitant has been developed and validated. The method employed, HPTLC aluminium plates precoated with silica gel as the stationary phase. The solvent system consisted of Dichloromethane: Ethyl acetate: Triethyleamine: Methanol (5: 3: 1.5: 0.5 v/v). The Rf value was found to 0.25±0.05 and 0.85±0.05 for Palonosetron HCl and Netupitant. Detection and quantitation were performed by densitrometric scanning at 241 nm for both drugs. The correlation coefficient of Palonosetron HCl and Netupitant was found to be 0.9991 and 0.9999 in a range of (0.01-0.06 μg/ml ) & (6-36 μ/ml) respectively. The method was validated for precision, recovery, robustness, LOQ, LOQ and Assay. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of investigated drug. The proposed developed HPTLC method can be applied for quantitative determination of Palonosetron HCl and Netupitant.

Keywords: HPTLC method, Palonosetron HCl, Netupitant, validation.