近年来,分析化学领域出现了向采用更绿色的色谱方法的显著转变,尽量减少对环境的影响。有效的策略包括用环境友好的替代品代替传统的有害有机溶剂,减少造成环境问题的危险化学品的使用。然而,在不使用缓冲液和有机溶剂的情况下分离药物是一个巨大的挑战。为了克服这一挑战,本研究采用了质量设计(QbD)和绿色分析化学(GAC)的组合进行方法开发。成功建立了同时测定盐酸奈必洛尔的高效液相色谱(HPLC)方法,替米沙坦,缬沙坦,和苯磺酸氨氯地平.该方法使用由0.1%甲酸在水(pH:2.5)和乙醇中的混合物组成的流动相。采用常规十八烷基二氧化硅(ODS)柱,并且利用在220nm处的UV检测。该方法在25-75μg/mL的替米沙坦和150-450μg/mL的盐酸奈比洛尔浓度范围内呈线性关系。缬沙坦,和苯磺酸氨氯地平,相关系数均大于0.999。替米沙坦的检测限(LOD)和定量(LOQ)确定为0.01和0.04μg/mL,盐酸奈比洛尔0.06和0.20μg/mL,氨氯地平苯磺酸盐0.08和0.25μg/mL,缬沙坦为0.14和0.46μg/mL,分别。所开发的方法经过了彻底的验证,包含各种参数,如线性度,准确度,精度,LOD,LOQ,鲁棒性,和坚固。观察到平均回收率值在98.86%和99.89%之间。对于日内和日间精确度,所证明的精确度始终高于98.98%,相对标准偏差小于2%。为了建立其稳健性,实施了基于设计质量的实验设计(DoE)方法。此外,该方法的环境友好性使用分析绿色度量(AGREE)和分析生态尺度进行了评估,既确认了其与可持续实践的一致性,又减少了生态影响。通过绿色溶剂选择工具(GSST)进一步评估了当前研究中使用的溶剂的可持续性,使用绿色分析工具(如分析方法绿色评分(AMGS))并使用最近发布的使用RGB评估工具的白色分析化学(WAC)评估开发的方法绿色度。通过采用这种更绿色的色谱法,这项研究有助于分析化学的持续努力,以促进可持续的做法,并尽量减少分析方法的环境足迹。
In recent years, the field of analytical chemistry has witnessed a notable shift towards the adoption of greener chromatographic methods, aiming to minimize the environmental impact. An effective strategy involves substituting conventional harmful organic solvents with environmentally friendly alternatives, reducing the use of hazardous chemicals that contribute to environmental concerns. However, separating drug substances without the use of buffers and organic solvents presence is a big challenge. To overcome this challenge, a combination of quality-by-design (QbD) and green analytical chemistry (GAC) was employed in this study for method development. A high-performance liquid chromatography (HPLC) method was successfully developed and validated for the simultaneous determination of Nebivolol hydrochloride, Telmisartan, Valsartan, and Amlodipine besylate. The method utilized a mobile phase composed of a mixture of 0.1 % formic acid in water (pH: 2.5) and ethanol. A regular octadecyl silica (ODS) column was employed, and UV detection at 220 nm was utilized. The method exhibited linearity within the concentration range of 25-75 μg/mL for Telmisartan and 150-450 μg/mL for Nebivolol Hydrochloride, Valsartan, and Amlodipine besylate and the correlation coefficient was greater than 0.999 for all the analytes. Limits of detection (LOD) and quantification (LOQ) were determined as 0.01 and 0.04 μg/mL for Telmisartan, 0.06 and 0.20 μg/mL for Nebivolol Hydrochloride, 0.08 and 0.25 μg/mL for Amlodipine besylate, and 0.14 and 0.46 μg/mL for Valsartan, respectively. The developed method underwent thorough validation, encompassing various parameters such as linearity, accuracy, precision, LOD, LOQ, robustness, and ruggedness. The mean recovery values were observed to range between 98.86 % and 99.89 %. The accuracy demonstrated was consistently above 98.98 % for both intra-day and inter-day precisions were with the relative standard deviations less than 2 %. To establish its robustness, a quality-by-design-based experimental design (DoE) approach was implemented. Additionally, the method\'s environmental friendliness was evaluated using the Analytical Greenness metric (AGREE) an analytical eco scale, both confirming its alignment with sustainable practices and reduced ecological impact. The sustainability of the solvent used in the current study was evaluated by Green Solvents Selecting Tool (GSST) Further, the developed method greenness was evaluated with the green analytical tools such as Analytical method greenness score (AMGS) and using the recently released White Analytical Chemistry (WAC) using RGB assessment tool. By employing this greener approach to chromatography method, this study contributes to the ongoing efforts in analytical chemistry to promote sustainable practices and minimize the environmental footprint of analytical methods.