Abstract

CHEMOMETRICS ASSISTED AND RP-HPLC METHODS FOR QUANTIFICATION OF NETUPITANT AND PALONOSETRON HYDROCHLORIDE BY QBD APPROCH: DEVELOPMENT AND VALIDATION.

Vasava Shilpa N.1 and Rajashree C. Mashru*

Abstract

A simple, sensitive, accurate, rapid, precise and economical Chemometrics assisted and RP-HPLC method By QbD approach for simultaneous Quantification of Netupitant (NETU) and Palonosetron hydrochloride (PALO) have been developed and validated. Chemometrics offers a useful approach for quantification of combined dosage form. Analysis was performed at 225 to 280nm with interval of 6nm for Netupitant and Palonosetron hydrochloride respectively. Chemometrics method were found to be linear, (R2=0.9998 & 0.9999) for all four methods CLS, ILS, PLS and PCR for NETU and PALO respectively. In HPLC method separation was achieved on Synchronies C-18 (250mm x 4.6mm, 5μm) column using mobile phase consisting mixture of 10 mM sodium acetate buffer, adjusted to pH 3.5 using Glacial acetic acid: acetonitrile: methanol in ratio of (10:50:40 v/v/v) pumped at flow rate 0.9 ml/min, at ambient temperature. QbD was applied for optimization of the method, Four variables buffer pH, wavelength, buffer ratio and flow rate have been varied and a model highlighting allowed design space was generated. By Applying DoE approach, a better chromatographic method was obtained and some of initially merged peaks in the chromatogram were resolved successfully and good symmetric peaks of NETU and PALO were also obtained. NETU and PALO were eluted at retention time of about 6.30 min, 3.55 min respectively. HPLC method was found to be linear (R2=0.9998) 6-36μg/ml for NETU and (R2 = 0.9999) 01-0.06 μg/ml for PALO. Both methods Chemometrics and RP-HPLC by QbD showed acceptable results for simultaneous estimation of NETU and PALO.

Keywords: Chemometrics assisted method, RP-HPLC, QbD approach, Netupitant, Palonosetron hydrochloride.