Article Details

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

Sagar S. Pandaa *, Ravi Kumar V. V. Beraa and Biswajit Sahua

a Department of Pharmaceutical Analysis & Quality Assurance, Roland Institute of Pharmaceutical Sciences (Affiliated to Biju Patnaik University of Technology, Odisha), Khodasingi, Brahmapur-760 010, Odisha, India

*For Correspondence: E-mail: sagarguddu2002@gmail.com

 

https://doi.org/10.53879/id.59.09.12191


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.

Year 2022 | Volume No. 59 | Issue No.9 | Page No. 74-81
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