RP-HPLC method development, validation, and greenness profile evaluation: Concurrent quantification of telmisartan and atorvastatin calcium in combined pharmaceutical formulation

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Abstract Objectives When formulating new strategies, contemporary analysts prioritize sustainability. Research in green analytical chemistry aims to replace hazardous reagents with eco-friendly alternatives and minimize waste generation. This study employed a comprehensive assessment of greenness evaluation tools. A newly validated RP-HPLC method was subsequently applied for the quantitative analysis of Telmisartan (TEL) and Atorvastatin calcium (ATV Ca) in both pure form and tablet formulation. Methods The analysis utilized an HPLC-UV Youngling Acme 9000 system with an Inertsil ODS RP column (250 × 4.6 mm, 5 μm), operating at 250 nm. The mobile phase, a 60:40 (v/v) blend of acetonitrile and phosphate buffer (pH 3.5), was delivered at 1.50 mL min −1 under isocratic conditions. Telmisartan (TEL) and Atorvastatin calcium (ATV Ca) showed retention times of 2.75 and 5.33 min, respectively. Results Calibration curves were developed to evaluate the linearity of TEL (10–100 μg mL −1 ) and ATV Ca (2.5–25 μg mL −1 ), showing a high R 2 of 0.999. The LOD and LOQ for TEL were 0.41 μg mL −1 and 0.23 μg mL −1 , while for ATV Ca, they were 1.246 μg mL −1 and 0.695 μg mL −1 , with recoveries averaging 98.59%–99.95% and 99.57%–99.98%, respectively. Validation of the method was performed following ICH guidelines. Moreover, the greenness assessment of the HPLC method was assessed using the AES, NEMI, AGP, AGREE, ComplexMoGAPI, AMGS, and BAGI. Conclusion This study validates the newly developed method and evaluates its environmental impact with multiple evaluation tools, confirming its eco-friendly nature, highlighting its potential as a responsible choice for analysing the mixture, especially in quality control labs and the pharmaceutical industry.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.