Abstract
<title>Abstract</title> <p> Atorvastatin is a widely prescribed lipid-lowering agent used for the management of hyperlipidemia and prevention of cardiovascular diseases. Reliable, sensitive, and environmentally sustainable analytical methods are essential for ensuring the quality, safety, and efficacy of atorvastatin pharmaceutical products. The objective of this study was to develop, optimize, and validate a rapid, sensitive, and green reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantitative determination of atorvastatin in pharmaceutical formulations. Chromatographic method development was performed by comparing a previously reported control method with two newly developed chromatographic conditions. The optimized method was achieved using a GL Sciences ODS-3V C18 column (250 × 4.6 mm, 5 µm) with a mobile phase consisting of 0.5% (v/v) aqueous acetic acid and ethanol (42.5:57.5, v/v) at a flow rate of 1.0 mL/min and UV detection at 240 nm. Method optimization demonstrated that the proposed method significantly improved chromatographic efficiency by reducing retention time compared with the control method ( <bold>p</bold> < 0.0001) while maintaining excellent peak characteristics. The optimized method exhibited enhanced sensitivity, with experimentally confirmed limits of detection and quantification of 5 ppm and 8 ppm, respectively, compared with a 10 ppm quantification limit for the control method. The developed method was validated according to analytical validation requirements for specificity, linearity, accuracy, precision, limit of detection, and limit of quantification. The method demonstrated excellent linearity over the concentration range of 0.004–0.800 mg/mL with a correlation coefficient ( <bold>R²</bold> ) of 1.000. Accuracy studies showed recoveries ranging from 96.88% to 103.13%, with an average recovery of 100.39%. The method showed good repeatability and intermediate precision with %CV values of 1.83% and 1.79%, respectively. Specificity evaluation confirmed the absence of interference from blank and placebo components, and peak purity analysis verified analyte specificity. The proposed RP-HPLC-UV method provides a rapid, sensitive, accurate, precise, and environmentally favorable approach for atorvastatin quantification. The utilization of ethanol as the major organic solvent reduces environmental impact and supports green analytical chemistry principles. The validated method is suitable for routine pharmaceutical quality control, manufacturing process monitoring, regulatory analysis, and potential application in bioequivalence studies. </p>