Development of a quality by design based eco-friendly RP-HPLC method for Ticagrelor and Aspirin

IF 6.2

Green Analytical Chemistry Pub Date : 2025-04-18 DOI:10.1016/j.greeac.2025.100271

Shivani Jani , Ujashkumar Shah , Jayvadan Patel , Monika Dua

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Abstract

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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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

背景替格瑞洛（TICA）和阿司匹林（ASP）是广泛应用的抗血小板药物。随着对可持续业务的日益重视，有必要采用绿色和强有力的分析程序来同时进行估计。目的设计并验证基于qbd的绿色反相高效液相色谱法同时测定药品中TICA和ASP含量的方法。方法采用响应面法（RSM）进行三因素析因设计，优化有机溶剂组成、流速、柱温等重要参数。优化的流动相为乙腈- 0.1%三氟乙酸（49:51,v/v），检测波长为225 nm。根据ICH Q2（R2）指南进行验证。绿色评价采用了ComplexGAPI、AGREE和分析生态量表。结果该方法线性良好(TICA: 18 ~ 135 μg/mL；ASP: 15-112.5 μg/mL；R²祝辞0.999)，精密度高（%RSD <1.5），稳健性好。绿色指标良好(AGREE: 0.79；Eco-Scale: 88)。结论建立了一种绿色、准确、可靠的反相高效液相色谱法，可同时测定TICA和ASP的含量。AQbD与绿色工具的结合使其在日常质量控制中得到应用，同时对环境的影响最小。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Green Analytical Chemistry

CiteScore

3.00

自引率

0.00%

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