Articles Accepted

APPLICATION OF ICH Q14 CONCEPT FOR CHEMOMETRICS-ASSISTED DEVELOPMENT OF SPECTROPHOTOMETRIC METHODS FOR ESTIMATION PIMAVANSERIN IN TABLETS
by Mr. SAGAR SUMAN PANDA, 02 Nov 2019

In the present study, the 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, 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 in tablets.

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November 2020
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