Katamesh Noha S, Abbas Ahmed Emad F, Halim Michael K, Abdel-Lateef Mohamed A, Mahmoud Shimaa A
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy (Girls), Al-Azhar University, Cairo, 11754, Egypt.
Analytical Chemistry Department, Faculty of Pharmacy, October 6 University, 6 October City, Giza, 12585, Egypt.
BMC Chem. 2024 Aug 9;18(1):149. doi: 10.1186/s13065-024-01254-8.
The development of sustainable analytical methodologies that minimize hazards, waste generation, and energy consumption has become crucial. This study introduces pioneering green‒blue-white approaches for the simultaneous quantification of montelukast sodium (MLK) and fexofenadine hydrochloride (FEX) in combination formulations. The first approach employs an ultra-performance liquid chromatographic method (UPLC) with a green micellar mobile phase of 0.02 M sodium dodecyl sulfate and 10% 1-pentanol (65:35%). The method demonstrated excellent resolution, peak symmetry, and a short analysis time, with retention times of 3.53 min for MLK and 1.67 min for FEX. The MLK and FEX linearities were 1-260 and 1.2-312 μg/mL, respectively. The second approach involves complementary built-in spectroscopic techniques (second derivative, third derivative, and ratio difference methods) using water as a solvent, providing a green, simple, low-cost alternative in laboratories where expensive chromatographic devices may not be readily available. The MLK and FEX linearities were 3-50 and 3-60 μg/mL, respectively. All methods were comprehensively validated and showed satisfactory results. The proposed methods demonstrated excellent linearity (r ≥ 0.9990), accuracy (recovery 98.5-101.5%), and precision (RSD ≤ 2%) across wide concentration ranges. A multifaceted evaluation was conducted to assess the environmental sustainability, real-world applicability, and economic viability of the proposed methods in comparison with previously reported techniques. This comprehensive assessment leveraged several state-of-the-art tools, including NEMI, ComplexGAPI, AGREE, ESA, BAGI, and RGB12. The suggested approaches exhibited favorable quadrant profiles in the NEMI and ComplexGAPI assessments, coupled with higher AGREE scores (0.90, 0.86) than reported (0.62, 0.74, 0.75, 0.69, 0.74, 0.74, and 0.75), in addition to higher ESA score (88, 92) than reported (75, 84, 85, 79, 82, 82, and 83), collectively affirming their environmentally friendly credentials. Moreover, we embraced the innovative notions of 'blueness' and 'whiteness' assessment by harnessing the recently formulated BAGI and RGB12 algorithms. The higher BAGI score (90, 82.5) than reported (72.5, 70, 70, 67.5, 67.5, 67.5, and 72.5), confirmed the excellent real-world applicability of the proposed methods, while the notable RGB12 indices (89.8, 88.1) than reported (67.8, 72.8, 71.5, 67.1, 73.7, 70.3, and 73.2), validated their cost-effectiveness and overall sustainability, contributing to an eco-friendly future for quality control processes.
开发能将危害、废物产生和能源消耗降至最低的可持续分析方法已变得至关重要。本研究引入了开创性的绿-蓝-白方法，用于同时定量复方制剂中的孟鲁司特钠（MLK）和盐酸非索非那定（FEX）。第一种方法采用超高效液相色谱法（UPLC），其绿色胶束流动相为0.02 M十二烷基硫酸钠和10% 1-戊醇（65:35%）。该方法具有出色的分离度、峰对称性和较短的分析时间，MLK的保留时间为3.53分钟，FEX的保留时间为1.67分钟。MLK和FEX的线性范围分别为1-260和1.2-312 μg/mL。第二种方法涉及使用水作为溶剂的互补内置光谱技术（二阶导数、三阶导数和比率差方法），为那些可能没有昂贵色谱设备的实验室提供了一种绿色、简单、低成本的替代方法。MLK和FEX的线性范围分别为3-50和3-60 μg/mL。所有方法均经过全面验证，结果令人满意。所提出的方法在宽浓度范围内表现出出色的线性（r ≥ 0.9990）、准确度（回收率98.5-101.5%）和精密度（RSD ≤ 2%）。与先前报道的技术相比，进行了多方面评估以评估所提出方法的环境可持续性、实际适用性和经济可行性。这种综合评估利用了几种先进工具，包括NEMI、ComplexGAPI、AGREE、ESA、BAGI和RGB12。所建议的方法在NEMI和ComplexGAPI评估中表现出良好的象限特征，并且与报道的相比具有更高的AGREE分数（0.90, 0.86）（报道分数为0.62, 0.74, 0.75, 0.69, 0.74, 0.74和0.75），此外ESA分数（88, 92）也高于报道分数（75, 84, 85, 79, 82, 82和83），共同证实了它们的环境友好资质。此外，我们通过利用最近制定的BAGI和RGB12算法，采用了“蓝色度”和“白度”评估的创新概念。与报道的相比，更高的BAGI分数（90, 82.5）（报道分数为72.5, 70, 70, 67.5, 67.5, 67.5和72.5）证实了所提出方法出色的实际适用性，而显著高于报道的RGB12指数（89.8, 88.1）（报道指数为67.8, 72.8, 71.5, 67.1, 73.7, 70.3和73.2）验证了它们的成本效益和整体可持续性，有助于质量控制过程实现生态友好的未来。
