Özdemir Elif, Dinç-Zor Şule
Department of Analytical Chemistry, Faculty of Pharmacy, Istanbul Yeni Yuzyil University, 34010 Istanbul, Türkiye.
Department of Chemistry, Yildiz Technical University, Davutpasa Campus, Istanbul, 34220 Türkiye.
J AOAC Int. 2025 Aug 4. doi: 10.1093/jaoacint/qsaf071.
In recent years, environmental impact, human health, and cost have become increasingly important in chromatographic analysis of pharmaceutical compounds. Traditional methods use organic solvents like acetonitrile (ACN) and methanol (MeOH), which are volatile, flammable, toxic, and environmentally harmful. By using the available comprehensive data on the effects of chemicals on human health and the environment, informed choices should be made about which chemicals are more suitable for a given synthesis or process, taking even a small step toward green chemistry.
In this study, the aim is to develop a green high-performance liquid chromatography (HPLC) method for the analysis of lidocaine by replacing the toxic solvents traditionally used in the mobile phases of classical chromatographic methods with greener alternatives. To achieve this, ethanol is used as the organic modifier in the mobile phase without compromising analytical performance, thereby enabling a transition to green chromatography.
The independent variables considered were the pH of the mobile phase, flow rate, and ethanol content in the mobile phase for the optimization step. Experimental runs were selected randomly, and a total of 15 experiments were conducted. Response parameters for each HPLC chromatogram were calculated, evaluated using regression analysis, and the accuracy of the results was tested using ANOVA.The Derringer desirable function was utilized to optimize the conditions. Accordingly, the optimal conditions determined were a mobile phase pH of 4.0, with a 1.3 mL/min flow rate and an ethanol content in the mobile phase of 25%.
The developed new green method offers an environmentally friendly, sensitive, and reliable alternative as lidocaine is determined using a high-performance liquid chromatography technique.
The developed and validated green HPLC method can be proposed as an alternative to the conventional HPLC methods reported by the USP and other sources, which are not environmentally or human health-friendly, for the analysis of lidocaine in pharmaceutical preparations. The use of ethanol instead of potentially toxic organic solvents minimizes harm to both the environment and analyst health. Additionally, the method offers advantages such as reduced analysis time, solvent and time savings, and the absence of labor-intensive sample and solvent preparation steps, making it an attractive option. It is considered that the developed method could be particularly useful in the pharmaceutical industry, especially in quality control laboratories where rapid and high-throughput analyses are conducted, as well as in R&D studies.
A green and sustainable HPLC method for lidocaine analysis was developed and validated. Chromatographic optimization was achieved using Design of Experiments and Derringer Desirability Function. The method showed high accuracy, precision, and suitability for routine analysis of injectable formulations. White Analytical Chemistry evaluation was performed using RGB12, AES, GAPI, and AGREE metrics. The developed method offers reduced analysis time, reagent consumption, resource use, and cost compared to reported RP-HPLC methods in the literature.
近年来，环境影响、人类健康和成本在药物化合物的色谱分析中变得越来越重要。传统方法使用乙腈（ACN）和甲醇（MeOH）等有机溶剂，这些溶剂具有挥发性、易燃性、毒性且对环境有害。通过利用现有的关于化学品对人类健康和环境影响的全面数据，应该对哪些化学品更适合特定的合成或过程做出明智的选择，朝着绿色化学迈出哪怕一小步。
在本研究中，目标是开发一种绿色高效液相色谱（HPLC）方法来分析利多卡因，用更环保的替代品取代传统色谱方法流动相中使用的有毒溶剂。为实现这一目标，在不影响分析性能的情况下，将乙醇用作流动相中的有机改性剂，从而实现向绿色色谱的转变。
在优化步骤中考虑的自变量是流动相的pH值、流速和流动相中的乙醇含量。实验运行是随机选择的，共进行了15次实验。计算每个HPLC色谱图的响应参数，使用回归分析进行评估，并使用方差分析测试结果的准确性。利用德林格合意函数优化条件。因此，确定的最佳条件是流动相pH值为4.0，流速为1.3 mL/min，流动相中乙醇含量为25%。
所开发的新绿色方法提供了一种环境友好、灵敏且可靠的替代方法，用于使用高效液相色谱技术测定利多卡因。
所开发并验证的绿色HPLC方法可作为USP和其他来源报道的传统HPLC方法的替代方法，传统方法对环境和人类健康不友好，用于分析药物制剂中的利多卡因。使用乙醇代替潜在有毒的有机溶剂可将对环境和分析人员健康的危害降至最低。此外，该方法具有分析时间缩短、节省溶剂和时间以及无需繁琐的样品和溶剂制备步骤等优点，使其成为一个有吸引力的选择。认为所开发的方法在制药行业可能特别有用，尤其是在进行快速和高通量分析的质量控制实验室以及研发研究中。
开发并验证了一种用于利多卡因分析的绿色可持续HPLC方法。使用实验设计和德林格合意函数实现了色谱优化。该方法对注射剂配方的常规分析显示出高准确性、精密度和适用性。使用RGB12、AES、GAPI和AGREE指标进行了白色分析化学评估。与文献中报道的反相HPLC方法相比，所开发的方法分析时间缩短、试剂消耗减少、资源使用减少且成本降低。
