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

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.

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Publication Details

Journal
Acta Chromatographica
Published
2025-08-12
DOI
https://doi.org/10.1556/1326.2025.01374
Citations
2
Primary Topic
Analytical Methods in Pharmaceuticals
Type
article
Field-Weighted Citation Impact
1.50
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article

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

Hope Onohuean, Bayapa Reddy Narapureddy, Banothu Bhadru, Rajasekhar Komarla Kumarachari et al.
2 citations
Acta Chromatographica
Analytical Methods in Pharmaceuticals
1.50
article

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

Hope Onohuean, Bayapa Reddy Narapureddy, Banothu Bhadru, Rajasekhar Komarla Kumarachari, Sarad Pawar Naik Bukke, Praveen Kumar Kusuma, Saraswathi Tenpattinam Shanmugam
article en
2 citations

Abstract

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.

Acta Chromatographica
SRM Institute of Science and Technology (IN), Kampala International University (UG), Meenakshi Academy of Higher Education and Research (IN), Mediciti Institute of Medical Sciences (IN), Delhi Pharmaceutical Science and Research University (IN), King Khalid University (SA)
Openalex Percentile: Top 17%
Analytical Methods in Pharmaceuticals
1.50
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