Analytical quality by design assisted RP-HPLC method for quantifying atorvastatin with green analytical chemistry perspective

Abstract

Analytical Quality by design and greener solvent methods were applied to optimize the High-Performance Liquid Chromatographic method for assessing atorvastatin calcium in bulk and pharmaceutical dosage forms are highlighted in the present work. The research used a rotatable central composite design, with the volume of ethanol and flow rate chosen as critical method variables for examining their impact on critical analytical attributes such as tailing factor, capacity factor, and theoretical plates. On a Zorbax Eclipse plus C18 column (150 × 4.6 mm, 5 µm), optimal chromatographic separation was achieved using 0.5% v/v aqueous acetic acid: ethanol (42.5: 57.5 v/v) flowing at 0.91 mL/min. Photodiode array detection was made at 246 nm. The retention time was 6.27 min for atorvastatin and the run time was 12 min. The linearity of the proposed method was perceived in the range of 10 to 150 µg/mL. The outcomes of other validation studies were likewise satisfactory. The suggested HPLC method was assessed concerning its greenness and ecological nature by the Green Analytical Procedure Index; Analytical Method Greenness Score; and analytical Eco-Scale score approach along with software-based evaluation AGREE metrics, which affirmed the excellent greenness and safety of the present work. This AQbD and greener technology were proven adequate for regular analysis of atorvastatin calcium in the pharmaceutical tablet dose without damaging the environment.