Shivani Jani , Ujashkumar Shah , Jayvadan Patel , Monika Dua
{"title":"基于质量设计的环保反相高效液相色谱法研究替格瑞洛和阿司匹林","authors":"Shivani Jani , Ujashkumar Shah , Jayvadan Patel , Monika Dua","doi":"10.1016/j.greeac.2025.100271","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Ticagrelor (TICA) and Aspirin (ASP) are widely prevalent antiplatelet drugs. With growing focus on sustainable operations, there is a necessity for green and strong analytical procedures for their simultaneous estimation.</div></div><div><h3>Objective</h3><div>To design and validate a green, QbD-based RP-HPLC technique for simultaneous estimation of TICA and ASP in drug products.</div></div><div><h3>Methods</h3><div>A 3-factor factorial design based on Response Surface Methodology (RSM) optimized important parameters: organic solvent composition, flow rate, and column temperature. The optimized mobile phase was acetonitrile and 0.1 % trifluoroacetic acid (49:51, v/v) and detection at 225 nm. Validation was done according to ICH Q2(R2) guidelines. Green evaluation employed ComplexGAPI, AGREE, and Analytical Eco-Scale.</div></div><div><h3>Results</h3><div>The procedure demonstrated good linearity (TICA: 18–135 μg/mL; ASP: 15–112.5 μg/mL; R² > 0.999), high precision ( %RSD <1.5), and robustness. Green metrics were good (AGREE: 0.79; Eco-Scale: 88).</div></div><div><h3>Conclusion</h3><div>A green, precise, and robust RP-HPLC method was established for the simultaneous estimation of TICA and ASP. Combination of AQbD and green tools lends support to its application in routine quality control with minimal environmental impact.</div></div>","PeriodicalId":100594,"journal":{"name":"Green Analytical Chemistry","volume":"13 ","pages":"Article 100271"},"PeriodicalIF":6.2000,"publicationDate":"2025-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Development of a quality by design based eco-friendly RP-HPLC method for Ticagrelor and Aspirin\",\"authors\":\"Shivani Jani , Ujashkumar Shah , Jayvadan Patel , Monika Dua\",\"doi\":\"10.1016/j.greeac.2025.100271\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Ticagrelor (TICA) and Aspirin (ASP) are widely prevalent antiplatelet drugs. With growing focus on sustainable operations, there is a necessity for green and strong analytical procedures for their simultaneous estimation.</div></div><div><h3>Objective</h3><div>To design and validate a green, QbD-based RP-HPLC technique for simultaneous estimation of TICA and ASP in drug products.</div></div><div><h3>Methods</h3><div>A 3-factor factorial design based on Response Surface Methodology (RSM) optimized important parameters: organic solvent composition, flow rate, and column temperature. The optimized mobile phase was acetonitrile and 0.1 % trifluoroacetic acid (49:51, v/v) and detection at 225 nm. Validation was done according to ICH Q2(R2) guidelines. Green evaluation employed ComplexGAPI, AGREE, and Analytical Eco-Scale.</div></div><div><h3>Results</h3><div>The procedure demonstrated good linearity (TICA: 18–135 μg/mL; ASP: 15–112.5 μg/mL; R² > 0.999), high precision ( %RSD <1.5), and robustness. Green metrics were good (AGREE: 0.79; Eco-Scale: 88).</div></div><div><h3>Conclusion</h3><div>A green, precise, and robust RP-HPLC method was established for the simultaneous estimation of TICA and ASP. Combination of AQbD and green tools lends support to its application in routine quality control with minimal environmental impact.</div></div>\",\"PeriodicalId\":100594,\"journal\":{\"name\":\"Green Analytical Chemistry\",\"volume\":\"13 \",\"pages\":\"Article 100271\"},\"PeriodicalIF\":6.2000,\"publicationDate\":\"2025-04-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Green Analytical Chemistry\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2772577425000679\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Green Analytical Chemistry","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2772577425000679","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Development of a quality by design based eco-friendly RP-HPLC method for Ticagrelor and Aspirin
Background
Ticagrelor (TICA) and Aspirin (ASP) are widely prevalent antiplatelet drugs. With growing focus on sustainable operations, there is a necessity for green and strong analytical procedures for their simultaneous estimation.
Objective
To design and validate a green, QbD-based RP-HPLC technique for simultaneous estimation of TICA and ASP in drug products.
Methods
A 3-factor factorial design based on Response Surface Methodology (RSM) optimized important parameters: organic solvent composition, flow rate, and column temperature. The optimized mobile phase was acetonitrile and 0.1 % trifluoroacetic acid (49:51, v/v) and detection at 225 nm. Validation was done according to ICH Q2(R2) guidelines. Green evaluation employed ComplexGAPI, AGREE, and Analytical Eco-Scale.
Results
The procedure demonstrated good linearity (TICA: 18–135 μg/mL; ASP: 15–112.5 μg/mL; R² > 0.999), high precision ( %RSD <1.5), and robustness. Green metrics were good (AGREE: 0.79; Eco-Scale: 88).
Conclusion
A green, precise, and robust RP-HPLC method was established for the simultaneous estimation of TICA and ASP. Combination of AQbD and green tools lends support to its application in routine quality control with minimal environmental impact.
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