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Abstract
Analytical techniques with sound scientific understanding and assured regulatory flexibilities for post-approval change management are the need of the current pharma scenario. In the present study, the recent concept of analytical procedure development is utilized along with quality management concepts to address the above issue. A new chromatographic method was developed for quantifying a novel antipsychotic agent pimavanserin tartarate in its dosage form. Critical method variables were identified and were investigated for their possible effect on critical analytical attributes viz. analyte retention, plate count and peak tailing. Methanol%, flow rate, and pH of mobile phase were the sorted critical method variables and were optimized using systematic Box-Behnken experimentation. The optimized chromatography used C18 column (150 × 4.6 mm, 5 µm) and methanol: phosphate buffer (pH 3.5) (80:20, v/v) as the mobile phase with a flow of 1 mL/min. Pimavanserin was separated from tartaric acid (resolution >7.5). Diode array detection at 226 nm presented accurate and precise quantification of pimavanserin. Linear responses were obtained over 0.5–100 µg/mL of pimavanserin. Further, the procedure performance capability index was measured by using Monte-Carlo simulation. In a nutshell, the present studies reveal the aptness of hyphenating chemometry with this novel concept for robust quantification of pimavanserin.
Graphical Abstract
Acknowledgments
The authors are thankful to Principal, Roland Institute of Pharmaceutical Sciences for providing the necessary research facilities.
Data availability
The authors confirm that the data supporting the findings of this study are available within the article.