Quality by design tool evaluated green stability-indicating UPLC content determination method for the Olanzapine and Samidorphan dosage form

Abstract

A green, environmentally friendly, quick, sensitive, cost-effective, stability-indicating, and analyst-friendly UPLC method for determining the content of Olanzapine and Samidorphan tablets formulation was developed since no method was reported in published articles. Waters CHS (50 × 2.1) mm, 1.7 um column, flow rate of 0.3 mL/min, injection volume of 1.0 µL, column temperature of 30 °C, detection wavelength of 232 nm, and a total runtime of 2 min were used to quantify the analytes. The mobile phase was composed of a solution containing 0.01 % di sodium phosphate and acetonitrile in the ratio of (30:70, v/v). The optimised technique has been validated, and the results are met the regulatory criteria. Olanzapine's accuracy results found from 99.5 % to 99.8 %, whereas Samidorphan accuracy results found from 99.4 % to 100.4 %. Olanzapine's precision and intermediate precision %RSD results found from 0.3 % to 0.7 %, whereas Samidorphan found from 0.5 % to 0.7 %. The correlation coefficient value for both analytes was found to be greater than 0.999 for the linearity range from 2.5 µg/mL to 15.0 µg/mL. Solution stability established for 24 hrs and filter compatibility studied. By studying forced degradation, the method stability indicating nature is proven. The method's robustness was assessed by utilising a design expert software tool. The method greenness was evaluated by using National method environmental index (NEMI), Green analytical procedure index (GAPI), Analytical greenness (AGREE) tools and Analytical Eco-Scale. AGREE value found 0.66 and eco-scale value found 81.