APPLICATION OF ICH Q14 CONCEPT FOR CHEMOMETRICS-ASSISTED DEVELOPMENT OF SPECTROPHOTOMETRIC METHODS FOR ESTIMATING PIMAVANSERIN IN TABLETS

Abstract

In the present study, a novel analytical procedure development concept is utilized along with a chemometrics approach. Two sensitive UV spectrophotometric methods were developed for quantifying a new antipsychotic agent, pimavanserin tartarate, in tablets. The scanning speed and sampling interval of the UV spectrophotometric methods were the critical method variables investigated and optimized by a face-centred cubic design during the development phase. A zero-order (222 nm) and a first derivative (maxima: 256 nm and minima: 283 nm) method displayed linear response over 0.5-100 µg mL-1, with impressive validation results. Further, the procedure robustness capability index was measured by using Monte Carlo simulation. In a nutshell, the present spectrophotometry based studies reveal aptness of the novel concept for developing robust and rapid analytical methods availing regulatory flexibilities for estimating pimavanserin tartarate in tablets